|
Section No. |
Regulation Name Product Code-Device Name |
Class |
|
876.1075 |
Gastroenterology-urology biopsy instrument. |
|
|
|
FCF - Instrument, Biopsy, Mechanical, Gastrointestinal |
II |
|
|
FCG - Biopsy Needle |
II |
|
|
FCI - Punch, Biopsy |
II |
|
|
FCK - Instrument, Biopsy, Suction |
II |
|
|
NLS - Instrument, Biopsy, Reprocessed |
II |
|
|
NMX - Needle And Needle Set, Gastro-Urology, Reprocessed |
II |
|
|
NON - Forceps, Biopsy, Non-Electric, Reprocessed |
I |
|
|
KNW - Instrument, Biopsy |
II |
|
876.1500 |
Endoscope and accessories. |
|
|
|
FBK - Endoscopic Injection Needle, Gastroenterology-Urology |
II |
|
|
FCX - Insufflator, Automatic Carbon-Dioxide For Endoscope |
II |
|
|
FDX - Endoscopic Cytology Brush |
II |
|
|
FFS - Image, Illumination, Fiberoptic, For Endoscope |
II |
|
|
FHO - Pneumoperitoneum Needle |
II |
|
|
FHP - Needle, Pneumoperitoneum, Simple |
II |
|
|
FHX - Jelly, Lubricating, For Transurethral Surgical Instrument |
II |
|
|
FTI - Lamp, Endoscope, Incandescent |
II |
|
|
OCT - Anti Fog Solution And Accessories, Endoscopy |
II |
|
|
OCZ - Endoscopic Grasping/Cutting Instrument, Non-Powered |
II |
|
|
KYH - Endoscope, Ophthalmic |
II |
|
|
MPA - Endoilluminator |
II |
|
|
GCI - Laryngoscope, Endoscope |
II |
|
876.1725 |
Gastrointestinal motility monitoring system. |
|
|
|
FES - Recorder, External, Pressure, Amplifier & Transducer |
II |
|
|
FFX - System, Gastrointestinal Motility (Electrical) |
II |
|
|
KLA - Monitor, Esophageal Motility, Anorectal Motility, And Tube |
II |
|
876.4300 |
Endoscopic electrosurgical unit and accessories. |
|
|
|
FAS - Electrode, Electrosurgical, Active, Urological |
II |
|
|
FDI - Snare, Flexible |
II |
|
|
FEH - Electrode, Flexible Suction Coagulator |
II |
|
|
FFI - System, Alarm, Electrosurgical |
II |
|
|
FHY - Jelly, Contact, For Transurethral Surgical Instrument |
II |
|
|
KGE - Forceps, Biopsy, Electric |
II |
|
|
KNS - Unit, Electrosurgical, Endoscopic (With Or Without Accessories) |
II |
|
876.4480 |
Electrohydraulic lithotriptor. |
|
|
|
FEO - Lithotriptor, Ultrasonic |
II |
|
|
FFK - Lithotriptor, Electro-Hydraulic |
II |
|
876.4500 |
Mechanical lithotriptor. |
|
|
|
FGK - Tripsor, Stone, Bladder |
II |
|
876.4620 |
Ureteral stent. |
|
|
|
FAD - Stent, Ureteral |
II |
|
876.4680 |
Ureteral stone dislodger. |
|
|
|
NQV - Catheter, Suction, Tracheobronchial, Reprocessed |
I |
|
|
NQT - Dislodger, Stone, Flexible, Ureteral, Reprocessed |
II |
|
|
NQU - Dislodger, Stone, Basket, Ureteral, Metal, Reprocessed |
II |
|
876.5010 |
Biliary catheter and accessories. |
|
|
|
GCA - Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection |
II |
|
|
LQR - Dislodger, Stone, Biliary |
II |
|
|
NML - Catheter, Biliary, Reprocessed |
II |
|
876.5090 |
Suprapubic urological catheter and accessories. |
|
|
|
FEW - Catheter, Malecot |
II |
|
|
FFA - Tube, Drainage, Suprapubic |
II |
|
876.5130 |
Urological catheter and accessories. |
|
|
|
EYB - Catheter, Ureteral, Gastro-Urology |
II |
|
|
EYC - Catheter, Upper Urinary Tract |
II |
|
|
EZC - Catheter, Coude |
II |
|
|
EZD - Catheter, Straight |
II |
|
|
EZL - Catheter, Retention Type, Balloon |
II |
|
|
FCM - Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) |
II |
|
|
FGF - Catheter, Ureteral Disposable (X-Ray) |
II |
|
|
FGH - Catheter, Double Lumen Female Urethrographic |
II |
|
|
FGI - Catheter, Urethrographic, Male |
II |
|
|
GBL - Catheter, Ureteral, General & Plastic Surgery |
N |
|
|
GBM - Catheter, Urethral |
II |
|
|
KNY - Accessories, Catheter, G-U |
II |
|
|
KOD - Catheter, Urological |
II |
|
|
LJH - System, Irrigation, Urological |
II |
|
|
MJC - Catheter, Urological (Antimicrobial) And Accessories |
II |
|
|
NWO - Kit, Catheter, Urinary (Exludes Hiv Testing) |
II |
|
876.5320 |
Nonimplanted electrical continence device. |
|
|
|
KPI - Stimulator, Electrical, Non-Implantable, For Incontinence |
II |
|
876.5470 |
Ureteral dilator. |
|
|
|
EZN - Dilator, Catheter, Ureteral |
II |
|
876.5520 |
Urethral dilator. |
|
|
|
FAH - Dilator, Urethral, Mechanical |
II |
|
876.5540 |
Blood access device and accessories. |
|
|
|
FJO - Plier, Tube |
I |
|
|
FKA - Dilator, Vessel |
II |
|
876.5665 |
Water purification system for hemodialysis. |
|
|
|
FIP - Subsystem, Water Purification |
II |
|
876.5820 |
Hemodialysis system and accessories. |
|
|
|
FIN - Tank, Holding, Dialysis |
II |
|
|
FJA - Manometer, Water |
II |
|
|
FJP - Adaptor, Y |
II |
|
|
FJZ - Declotting Tray, Kit (Including Contents) |
II |
|
|
FKH - Solution-Test Standard-Conductivity, Dialysis |
II |
|
|
FKM - Adaptor, Fistula |
II |
|
|
FLB - Meter, Conductivity, Induction, Remote Type |
II |
|
|
MNV - Strip, Dialysate Ph Indicator |
II |
|
876.5880 |
Isolated kidney perfusion and transport system and accessories. |
|
|
|
KDK - Container, Transport, Kidney |
II |
|
|
KDN - System, Perfusion, Kidney |
II |
|
876.5980 |
Gastrointestinal tube and accessories. |
|
|
|
BSS - Tube, Nasogastric |
II |
|
|
EZK - Catheter, Retention Type |
II |
|
|
FCB - Bag, Hemostatic |
II |
|
|
FEF - Tube, Single Lumen, With Mercury Wt Balloon For Intestinal Intubation And / Or Decompression |
II |
|
|
FEG - Tube, Double Lumen For Intestinal Decompression And/Or Intubation |
II |
|
|
FFW - String And Tubes, Gastrointestinal, To Locate Internal Bleeding |
II |
|
|
FHT - Set, Gavage, Infant, Sterile |
II |
|
|
FRQ - Tube, Levine |
II |
|
|
GBT - Catheter, Rectal |
II |
|
|
KDH - Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration |
II |
|
|
KGC - Tube, Gastro-Enterostomy |
II |
|
|
LCG - Intestinal Splinting Tubes |
II |
|
|
PBP - Rectal Insert |
II |
|
|
EYN - Tray, Irrigation, Sterile |
II |
|
|
NGU - Balloon, Liver Tamponade |
II |
|