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
7713 General & Plastic Surgery devices
5376–5400 of 7713
Cleared Aug 04, 1994
HYDROCOLLOID WOUND DRESSING
K943258 · Convatec, A Division of E.R. Squibb & Sons
KMF · Bandage, Liquid · 29d
Cleared Jul 29, 1994
COVERLET ADHESIVE DRESSING
K940378 · Beiersdorf, Inc.
KGX · Tape And Bandage, Adhesive · 184d
Cleared Jul 28, 1994
GORETEX SAM FACIAL IMPLANT
K942280 · W.L. Gore & Associates, Inc.
FWP · Prosthesis, Chin, Internal · 79d
Cleared Jul 28, 1994
GORE-TEX FACIAL IMPLANT
K933367 · W.L. Gore & Associates, Inc.
FWP · Prosthesis, Chin, Internal · 384d
Cleared Jul 27, 1994
OLYMPUS SUPERVIEW LAPAROSCOPE FOR GENERAL SURGERY
K942839 · Olympus America, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 42d
Cleared Jul 27, 1994
DEKNATEL(TM) PLEUR-EVAC(R) THORACIC CATHETER
K925243 · Deknatel, Inc.
GBX · Catheter, Irrigation · 649d
Cleared Jul 26, 1994
BIOPLAR FORCEPS
K943231 · Cook Urological, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 20d
Cleared Jul 26, 1994
CURAFIL WOUND GEL DRESSING
K943073 · Kendall Healthcare Products Co. Div.Of Tyco Health
MGQ · Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic · 28d
Cleared Jul 26, 1994
SURGICAL SUTURE, NONABSORABLE STAINLESS STEEL
K930740 · Deknatel, Inc.
GAQ · Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile · 529d
Cleared Jul 26, 1994
SUTURES POLYPROP., POLYETHELINE, NYLON & SILK
K930739 · Deknatel, Inc.
GAP · Suture, Nonabsorbable, Silk · 529d
Cleared Jul 26, 1994
SURGICAL SUTURES, PGL, GUT, DEKLENE, OPTHAMEND ETC
K930738 · Deknatel, Inc.
GAL · Suture, Absorbable, Natural · 529d
Cleared Jul 25, 1994
ELECTROSURGICAL CUTTING & COAGULATION DEVICE
K942489 · Megadyne Medical Products, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 61d
Cleared Jul 25, 1994
CANDELA Q-SWITCHED, FREQUENCY DOUBLED ND
K942152 · Candela Laser Corp.
GEX · Powered Laser Surgical Instrument · 83d
Cleared Jul 21, 1994
ANGLED DISSECTORS MODELS 8383.581/582/571
K940948 · Richard Wolf Medical Instruments Corp.
GCJ · Laparoscope, General & Plastic Surgery · 143d
Cleared Jul 21, 1994
AESCULAP FLEXIBLE TROCAR INSTRUMENT SET
K935243 · Aesculap, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 262d
Cleared Jul 20, 1994
POLYSKIN(R) M.R. MOIST RESPONSIVE TRANSPARENT DRESSING
K942774 · The Kendal Co.
MGP · Dressing, Wound And Burn, Occlusive · 37d
Cleared Jul 19, 1994
DEROYAL SURGICAL'S ENDOSCOPIC SPECIMEN RETRIEVAL POUCH
K942879 · Deroyal Industries, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 32d
Cleared Jul 18, 1994
IMPLANTECH DORSAL NASAL IMPLANT
K942876 · Implantech Associates, Inc.
FZE · Prosthesis, Nose, Internal · 31d
Cleared Jul 13, 1994
CONMED SELECT-ONE LAPAROSCOPIC ELECTROSURGICAL BLADE
K942892 · Conmedcorp
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 23d
Cleared Jul 12, 1994
VISITEC PRECISE-POINT
K942234 · Visitec Co.
GAP · Suture, Nonabsorbable, Silk · 64d
Cleared Jul 08, 1994
LIFTING DISTENTION BALLOON SYSTEM
K942678 · Origin Medsystems, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 31d
Cleared Jul 08, 1994
COHERENT VERSAPULSE 2.1U /1.06U COMPACT SURGICAL LASER, MODELS A & B
K933318 · Lumenis, Inc.
GEX · Powered Laser Surgical Instrument · 354d
Cleared Jul 07, 1994
ORIGIN BALLOON RETRACTOR
K942491 · Origin Medsystems, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 43d
Cleared Jul 01, 1994
MKM (MULTIPLE COORDINATE MANIPULATOR) SYSTEM
K942233 · Carl Zeiss, Inc.
EPT · Microscope, Surgical · 53d
Cleared Jun 30, 1994
SHARPLAN SWIFTLASE 765/766/767 FLASHSCAN
K941312 · Sharplan Lasers, Inc.
GEX · Powered Laser Surgical Instrument · 104d

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All categories 7713 GEX Powered Laser Surgical Instrument 1148 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