Recognized Consensus Standards

Recognition List Number: 028 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 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
Regulation Number	Device Name	Device Class	Product Code
§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	Razor, Surgical	Class 1	LWK
§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
Regulation Number	Device Name	Device Class	Product Code
§888.4540	Bit, Drill	Class 1	HTW

Relevant Guidance:

There is no relevant guidance developed at this time.

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