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Recognized Consensus Standards

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Recognition List Number: 028 FR Publication Date: 03/16/2012 

Part B: Supplementary Information

Recognition Number 6-272: ASTM F2062-00 (Reapproved 2011), standard specification for square drive interconnections on surgical instruments. (General Plastic Surgery/General Hospital)

Date of Standard: 2000. 
Address of Standards Development Organization:
 ASTM International (ASTM)
  100 Barr Harbor Drive
  West Conshohocken, PA 19428-2959
 
CDRH Offices and Divisions associated with recognized standards:
(1)OFFICE OF DEVICE EVALUATION (ODE)
(2)OFFICE OF COMPLIANCE (OC)
Devices Affected:
Surgical Instruments
Processes Affected:
Premarket Notification and Design Controls
Type of Standard:
 Vertical, National
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§876.4730 Surgical Instruments, G-U, Manual (And Accessories) Class 1 KOA
No product code information listed for §878.4540
§878.4800 Orthopedic Tray Class 1 OJH
§878.4800 Needle, Biopsy, Cardiovascular Class 1 DWO
§878.4800 Knife, Surgical Class 1 EMF
§878.4800 Apparatus, Suturing, Stomach And Intestinal Class 1 FHM
§878.4800 Needle, Gastro-Urology Class 1 FHR
§878.4800 Lancet, Blood Class 1 FMK
§878.4800 Tray, Surgical, Instrument Class 1 FSM
§878.4800 Loupe, Diagnostic/Surgical Class 1 FSP
§878.4800 Mirror, General & Plastic Surgery Class 1 FTX
§878.4800 Tape, Measuring, Rulers And Calipers Class 1 FTY
§878.4800 Chisel, Surgical, Manual Class 1 FZO
§878.4800 Contractor, Surgical Class 1 FZR
§878.4800 Curette, Surgical, General Use Class 1 FZS
§878.4800 Cutter, Surgical Class 1 FZT
§878.4800 Expander, Surgical, Skin Graft Class 1 FZW
§878.4800 Guide, Surgical, Instrument Class 1 FZX
§878.4800 Hammer, Surgical Class 1 FZY
§878.4800 Needle, Aspiration And Injection, Disposable Class 1 GAA
§878.4800 Needle, Suturing, Disposable Class 1 GAB
§878.4800 Rasp, Surgical, General & Plastic Surgery Class 1 GAC
§878.4800 Retractor Class 1 GAD
§878.4800 Snare, Surgical Class 1 GAE
§878.4800 Spatula, Surgical, General & Plastic Surgery Class 1 GAF
§878.4800 Stapler, Surgical Class 1 GAG
§878.4800 Stylet, Surgical, General & Plastic Surgery Class 1 GAH
§878.4800 Stripper, Vein, Reusable Class 1 GAI
§878.4800 Stripper, Vein, Disposable Class 1 GAJ
§878.4800 Retainer, Surgical Class 1 GCZ
§878.4800 Guide, Needle, Surgical Class 1 GDF
§878.4800 Hook, Surgical, General & Plastic Surgery Class 1 GDG
§878.4800 Gouge, Surgical, General & Plastic Surgery Class 1 GDH
§878.4800 Dissector, Surgical, General & Plastic Surgery Class 1 GDI
§878.4800 Clamp, Surgical, General & Plastic Surgery Class 1 GDJ
§878.4800 Needle, Suturing, Reusable Class 1 GDL
§878.4800 Needle, Aspiration And Injection, Reusable Class 1 GDM
§878.4800 Knife, Amputation Class 1 GDN
§878.4800 Applier, Surgical, Clip Class 1 GDO
§878.4800 Saw, Manual And Accessories Class 1 GDR
§878.4800 Scalpel, One-Piece Class 1 GDX
§878.4800 Handle, Scalpel Class 1 GDZ
§878.4800 Cannula, Surgical, General & Plastic Surgery Class 1 GEA
§878.4800 Brush, Scrub, Operating-Room Class 1 GEC
§878.4800 Brush, Dermabrasion, Manual Class 1 GED
§878.4800 Brush, Biopsy, General & Plastic Surgery Class 1 GEE
§878.4800 Applier, Staple, Surgical, Class 1 GEF
§878.4800 Elevator, Surgical, General & Plastic Surgery Class 1 GEG
§878.4800 Carrier, Ligature Class 1 GEJ
§878.4800 Forceps, General & Plastic Surgery Class 1 GEN
§878.4800 File, Surgical, General & Plastic Surgery Class 1 GEO
§878.4800 Blade, Scalpel Class 1 GES
§878.4800 Osteotome, Manual Class 1 GFI
§878.4800 Mallet, Surgical, General & Plastic Surgery Class 1 GFJ
§878.4800 Applier, Hemostatic Clip Class 1 HBT
§878.4800 Instrument, Ligature Passing And Knot Tying Class 1 HCF
§878.4800 Hemostat Class 1 HRQ
§878.4800 Saw Class 1 HSO
§878.4800 Pliers, Surgical Class 1 HTC
§878.4800 Forceps Class 1 HTD
§878.4800 Elevator Class 1 HTE
§878.4800 Curette Class 1 HTF
§878.4800 Rasp Class 1 HTR
§878.4800 Instrument, Cutting, Orthopedic Class 1 HTZ
§878.4800 Osteotome Class 1 HWM
§878.4800 Clamp Class 1 HXD
§878.4800 Mallet Class 1 HXL
§878.4800 Spatula, Orthopedic Class 1 HXR
§878.4800 Tape, Orthopedic Class 1 HXT
§878.4800 Forceps, Wire Holding Class 1 HYA
§878.4800 Cannula, Ear Class 1 JYC
§878.4800 Chisel, Mastoid Class 1 JYD
§878.4800 Cannula, Sinus Class 1 KAM
§878.4800 Chisel, Nasal Class 1 KAN
§878.4800 Cannulae, Bronchial Class 1 KCE
§878.4800 Instrument, Surgical, Disposable Class 1 KDC
§878.4800 Kit, Surgical Instrument, Disposable Class 1 KDD
§878.4800 Hook, Bone Class 1 KIK
§878.4800 Tray, Surgical Class 1 LRP
§878.4800 Scissors, General, Surgical Class 1 LRW
§878.4800 Punch, Surgical Class 1 LRY
§878.4800 Screwdriver, Surgical Class 1 LRZ
§878.4800 Vise, Bench, Surgical Class 1 LSA
§878.4800 Razor, Surgical Class 1 LWK
§878.4800 Scrapper, Skin Specimen Class 1 LXK
§878.4800 Label Or Tag, Sterile Class 1 LYV
§878.4800 Instrument, Manual, Surgical, General Use Class 1 MDM
§878.4800 Needle, Tumor Localization Class 1 MIJ
§878.4800 Device, Percutaneous, Biopsy Class 1 MJG
§878.4800 Extractor, Vein Class 1 NJZ
§878.4800 Needle, Biopsy, Cardiovascular, Reprocessed Class 1 NLK
§878.4800 Needle, Gastro-Urology, Reprocessed Class 1 NMU
§878.4800 Biospy Device, Percutaneous, Reprocessed Class 1 NNA
§878.4800 Needle, Aspiration And Needle, Reprocessed Class 1 NNC
§878.4800 Aspiration Tray (Kit) Class 1 OJT
§878.4800 Skin Prep Tray (Kit) Class 1 OJU
§878.4800 Single Use Instrument Tray Kit Class 1 OJV
§888.4540 Bit, Drill Class 1 HTW
FDA Technical Contact:
 Long Chen, Ph.D.
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 1461
  Silver Spring MD 20993
  301/796-6389
  email: long.chen@fda.hhs.gov
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