FDA Review Panel · SU

FDA 510(k) General & Plastic Surgery Devices

FDA 510(k) General & Plastic Surgery Devices - Regulatory Overview

FDA 510(k) general and plastic surgery devices represent the largest 510(k) category with 18,104 submissions since 1976. The FDA review panel code is SU.

This panel covers a broad range of surgical equipment:

  • Electrosurgical units (ESU) - monopolar and bipolar cutting and coagulation
  • Surgical lasers - CO2, Nd:YAG, diode and excimer surgical lasers
  • Laparoscopic instruments - trocars, graspers, staplers, clip appliers
  • Wound care and closure - negative pressure therapy, staples, tissue adhesives
  • Aesthetic devices - body contouring, skin resurfacing, fat reduction systems

18256
Total
18211
Cleared
137d
Avg (2y)
1976
Since
7738 General & Plastic Surgery devices
6676–6700 of 7738
Cleared Sep 15, 1986
MODEL 8-B CO2 LASER FOR GENERAL & PLASTIC SURGERY
K862423 · Directed Energy, Inc.
GEX · Powered Laser Surgical Instrument · 82d
Cleared Sep 12, 1986
NEOMED NON GEL-R TOTAL ADHESIVE CONDUCT. ELECTRODE
K863360 · Richards Medical Co., Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 10d
Cleared Aug 29, 1986
NEW USE FOR ACUVAC SUCTION RESERVOIR 400CC
K863201 · Allergan, Inc.
GCY · Apparatus, Suction, Single Patient Use, Portable, Nonpowered · 10d
Cleared Aug 29, 1986
THORACIC CATHETER (CHEST DRAINAGE TUBE)
K863142 · Sheridan Catheter Corp.
GBS · Catheter, Ventricular, General & Plastic Surgery · 14d
Cleared Aug 29, 1986
PERCU GUIDE I (LOOP TYPE)
K863090 · E-Z-Em, Inc.
GDF · Guide, Needle, Surgical · 16d
Cleared Aug 20, 1986
MODIFIED SURGICAL STARTER KIT
K862961 · Devon Industries, Inc.
· 16d
Cleared Aug 20, 1986
WOUND MANAGER(TM) - STERILE
K862935 · Convatec, A Division of E.R. Squibb & Sons
NAD · Dressing, Wound, Occlusive · 16d
Cleared Aug 18, 1986
A.C.L. GUIDE KIT
K862564 · Aspen Laboratories, Inc.
FZX · Guide, Surgical, Instrument · 46d
Cleared Aug 14, 1986
MICRO-AIRE CAST CUTTER BLADES
K862922 · Micro-Aire Surgical Instruments, Inc.
· 13d
Cleared Aug 14, 1986
HEAVY DUTY (HD) SUCTION UNITS (W/CANNULAS)
K862569 · Jedmed Instrument Co.
BTA · Pump, Portable, Aspiration (manual Or Powered) · 38d
Cleared Aug 12, 1986
OSTEOTOMY DRAINAGE TUBE
K862584 · Treace Medical, Inc.
GBS · Catheter, Ventricular, General & Plastic Surgery · 36d
Cleared Aug 12, 1986
COOPER LASER SONICS ND: YAG LASER, MODEL 8008
K853117 · Cooper Lasersonics, Inc.
GEX · Powered Laser Surgical Instrument · 383d
Cleared Aug 11, 1986
MICRO-AIRE REPLACE OTOLOGY BURS/ZIM HALL SUR INSTR
K862852 · Micro-Aire Surgical Instruments, Inc.
GFF · Bur, Surgical, General & Plastic Surgery · 13d
Cleared Aug 11, 1986
SPUNGUARD HOSPITAL COVERALL
K862804 · Kimberly-Clark Corp.
· 20d
Cleared Aug 04, 1986
HOLLISTER WOUND CARE BARRIER
K862572 · Hollister, Inc.
FRO · Dressing, Wound, Drug · 28d
Cleared Jul 30, 1986
TEMPORARY HEMO CLIP, 07-096-01/02 & APPLY FORCEP
K862696 · Downs Surgical , Ltd.
HBT · Applier, Hemostatic Clip · 15d
Cleared Jul 30, 1986
JEDMED CCD CAMERA SYSTEM
K862664 · Jedmed Instrument Co.
FWD · Camera, Television, Microsurgical, Without Audio · 16d
Cleared Jul 30, 1986
TREACE MEDICAL MICRO INSTRUMENT WIPE
K862582 · Treace Medical, Inc.
· 23d
Cleared Jul 23, 1986
STERILE DISPOSABLE TROCAR-SLEEVE DEVICES
K862611 · United States Surgical, A Division of Tyco Healthc
GCJ · Laparoscope, General & Plastic Surgery · 15d
Cleared Jul 23, 1986
REFLEX(TM) CLIP APPLIER
K862404 · Richard-Allan Medical Ind., Inc.
FZP · Clip, Implantable · 28d
Cleared Jul 23, 1986
ELECTRO-SURGICAL PENCILS
K861742 · Stryker Corp.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 78d
Cleared Jul 21, 1986
LITE TOUCH GELFOAM INSERT
K862583 · Treace Medical, Inc.
· 14d
Cleared Jul 09, 1986
JOHNSON & JOHNSON PETROLATUM GAUZE NON ADHER DRESS
K862163 · Johnson & Johnson Professionals, Inc.
FRO · Dressing, Wound, Drug · 33d
Cleared Jul 08, 1986
ARMBOARDS, REUSABLE AND DISPOSABLE
K862111 · Abco Dealers, Inc.
· 35d
Cleared Jul 08, 1986
MEDSURG CUSTOM DRESSING TRAYS
K861693 · Medsurg Industries, Inc.
· 67d

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All categories 7738 GEX Powered Laser Surgical Instrument 1172 GEI Electrosurgical, Cutting & Coagulation & Accessories 1108 GCJ Laparoscope, General & Plastic Surgery 682 FRO Dressing, Wound, Drug 222 FTL Mesh, Surgical, Polymeric 186 GDW Staple, Implantable 159 NAY System, Surgical, Computer Controlled Instrument 158 OHT Light Based Over-the-counter Hair Removal 142 OHS Light Based Over The Counter Wrinkle Reduction 120 OMP Negative Pressure Wound Therapy Powered Suction Pump 106 FZP Clip, Implantable 101 GAT Suture, Nonabsorbable, Synthetic, Polyethylene 93 LFL Instrument, Ultrasonic Surgical 85 KGN Wound Dressing With Animal-derived Material(s) 85 GEH Unit, Cryosurgical, Accessories 78