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

18327
Total
18282
Cleared
139d
Avg (2y)
1976
Since
14180 General & Plastic Surgery devices
10876–10900 of 14180
Cleared Jan 14, 1994
BURN GAUZE PADS
K935935 · Mcneil Healthcare, Inc.
EFQ · Gauze/sponge, Internal · 32d
Cleared Jan 14, 1994
CONFORMING ROLL
K935936 · Mcneil Healthcare, Inc.
EFQ · Gauze/sponge, Internal · 32d
Cleared Jan 14, 1994
POST OP SPONGE
K935937 · Mcneil Healthcare, Inc.
EFQ · Gauze/sponge, Internal · 32d
Cleared Jan 14, 1994
BANDAGE ROLLS, STRETCH GAUZE ROLLS, TEXTURED GAUZE ROLLS
K935938 · Mcneil Healthcare, Inc.
EFQ · Gauze/sponge, Internal · 32d
Cleared Jan 14, 1994
GAUZE FLUFF
K935939 · Mcneil Healthcare, Inc.
EFQ · Gauze/sponge, Internal · 32d
Cleared Jan 14, 1994
GAUZE SPONGE
K935940 · Mcneil Healthcare, Inc.
EFQ · Gauze/sponge, Internal · 32d
Cleared Jan 14, 1994
READY CUT GAUZE GAUZE BOLTS
K935941 · Mcneil Healthcare, Inc.
EFQ · Gauze/sponge, Internal · 32d
Cleared Jan 13, 1994
PHX TECHNOLOGIES CORP., 5MM, 10MM, AND 12MM BLUNT-TIPPED TROCAR OBTURATORS AND MATCHED TROCAR TUBES
K934279 · Phx Technologies Corp.
GCJ · Laparoscope, General & Plastic Surgery · 135d
Cleared Jan 13, 1994
PHX TECHNOLOGIES CORP., 10 MM THORACOSCOPY SCRAPPER DEVICE
K934280 · Phx Technologies Corp.
GCJ · Laparoscope, General & Plastic Surgery · 135d
Cleared Jan 13, 1994
SURGICAL LAPAROTOMY SPONGE X-RAY DETECTABLE
K935942 · Mcneil Healthcare, Inc.
EFQ · Gauze/sponge, Internal · 31d
Cleared Jan 12, 1994
ALLKARE BARRIER WIPE
K925004 · Convatec, A Division of E.R. Squibb & Sons
KMF · Bandage, Liquid · 467d
Cleared Jan 10, 1994
GIANTURCO-HELFRICH HERNIS MESH
K931936 · Cook, Inc.
FTL · Mesh, Surgical, Polymeric · 266d
Cleared Jan 10, 1994
SLASE 210 & SLASE 210 PLUS HOLMIUM LASER SYSTEMS
K933007 · Sunrise Technologies, Inc.
GEX · Powered Laser Surgical Instrument · 203d
Cleared Jan 10, 1994
PILLING LAPAROSCOPIC INSTRUMENTATION
K934427 · Pilling Co.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 122d
Cleared Jan 10, 1994
BRENNEN MEDICAL STERILE SALINE SOLUTION
K935060 · Brennen Medical, Inc.
KMF · Bandage, Liquid · 82d
Cleared Jan 07, 1994
DEXON S, DEXON PLUS, AND DEXON II POLYCOLIC ACID
K930588 · Davis & Geck, Inc.
GAM · Suture, Absorbable, Synthetic, Polyglycolic Acid · 337d
Cleared Jan 07, 1994
ETHICON* MONOCRYL (POLIGLECAPRONE 25) SUTURE
K930772 · Ethicon, Inc.
GAM · Suture, Absorbable, Synthetic, Polyglycolic Acid · 325d
Cleared Jan 07, 1994
ETHI-PACK* SURGICAL STAINLESS STEEL SUTURE
K931271 · Ethicon, Inc.
GAQ · Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile · 305d
Cleared Jan 07, 1994
ECLIPSE 3200 FOR USE IN UROLOGY APPLICATIONS
K931305 · Cardiogenes
GEX · Powered Laser Surgical Instrument · 298d
Cleared Jan 07, 1994
AESCULAP MANUAL ENDOSCOPIC INSTRUMENTS
K932346 · Aesculap, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 238d
Cleared Jan 06, 1994
10MM DISPOSABLE, STERILE SUCTION CANNULA
K933789 · Phx Technologies Corp.
GCJ · Laparoscope, General & Plastic Surgery · 155d
Cleared Jan 06, 1994
5MM DISPOSABLE SUCTION-IRRIGATION CANNULA
K933790 · Phx Technologies Corp.
GCJ · Laparoscope, General & Plastic Surgery · 155d
Cleared Jan 03, 1994
ERCP CATHETER, HYDROPHILIC COATED
K932205 · Wilson-Cook Medical, Inc.
GBX · Catheter, Irrigation · 242d
Cleared Jan 03, 1994
MEGABEAM LATERAL FIRE FIBER OPTIC DELIVERY SYST
K934008 · Ceram Optec, Inc.
GEX · Powered Laser Surgical Instrument · 139d
Cleared Dec 30, 1993
CARAPACE CATARACT TRAYS
K931673 · Carapace, Inc.
LRO · General Surgery Tray · 268d

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All categories 14180 GEX Powered Laser Surgical Instrument 2399 GEI Electrosurgical, Cutting & Coagulation & Accessories 1904 GCJ Laparoscope, General & Plastic Surgery 1123 FRO Dressing, Wound, Drug 586 FTL Mesh, Surgical, Polymeric 317 GDW Staple, Implantable 262 GEH Unit, Cryosurgical, Accessories 214 OMP Negative Pressure Wound Therapy Powered Suction Pump 213 KGN Wound Dressing With Animal-derived Material(s) 174 NAY System, Surgical, Computer Controlled Instrument 163 OHT Light Based Over-the-counter Hair Removal 163 OHS Light Based Over The Counter Wrinkle Reduction 161 GAT Suture, Nonabsorbable, Synthetic, Polyethylene 160 EFQ Gauze/sponge, Internal 157 KMF Bandage, Liquid 155