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
14317 General & Plastic Surgery devices
13976–14000 of 14317
Cleared Jan 09, 1980
TRACHEOTOMY SPONGE, NON-ADHERENT
K792613 · American Medical Disposable, Inc.
EFQ · Gauze/sponge, Internal · 22d
Cleared Jan 09, 1980
TRACHOETOMY SPONGE, NON-ADHERENT CELL
K792614 · American Medical Disposable, Inc.
EFQ · Gauze/sponge, Internal · 22d
Cleared Jan 09, 1980
CELLULOSE TRACHE SPONGE
K792615 · American Medical Disposable, Inc.
EFQ · Gauze/sponge, Internal · 22d
Cleared Jan 09, 1980
TRACHEOTOMY SPONGE, NON-ADHERENT W/HDPE
K792616 · American Medical Disposable, Inc.
EFQ · Gauze/sponge, Internal · 22d
Cleared Jan 09, 1980
TRACHEOTOMY SPONGE, NON-ADHERENT BARRIER
K792617 · American Medical Disposable, Inc.
EFQ · Gauze/sponge, Internal · 22d
Cleared Jan 09, 1980
TRACHEOTOMY SPONGE, NON-WOVEN DELNET
K792618 · American Medical Disposable, Inc.
EFQ · Gauze/sponge, Internal · 22d
Cleared Dec 31, 1979
HANSAPOR STERILE
K792360 · Beiersdorf, Inc.
FPX · Strip, Adhesive, Closure, Skin · 40d
Cleared Dec 27, 1979
DEXIDE DIS. SUR. SCRUB SPONGE W/PARACHLO
K792272 · Dexide, Inc.
GEC · Brush, Scrub, Operating-room · 44d
Cleared Dec 27, 1979
VAGINAL PACKING
K792431 · American Medical Disposable, Inc.
EFQ · Gauze/sponge, Internal · 29d
Cleared Dec 27, 1979
FEEDING TUBE PLACEMENT STYLET
K792468 · Biosearch Medical Products, Inc.
FZX · Guide, Surgical, Instrument · 24d
Cleared Dec 20, 1979
TEMPORARY BURN SHEET WITH PERFORATED
K792432 · American Medical Disposable, Inc.
FPY · Sheet, Burn · 22d
Cleared Dec 20, 1979
TEMPORARY BURN SHEET WITH PERFORATED
K792433 · American Medical Disposable, Inc.
FPY · Sheet, Burn · 22d
Cleared Dec 18, 1979
DIATHERMIC SNARE (CRESENT TYPE)
K792343 · Mill-Rose Laboratory
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 29d
Cleared Dec 10, 1979
DEXIDE DISPOSABLE SURGICAL SCRUB SPONGE
K792271 · Dexide, Inc.
GEC · Brush, Scrub, Operating-room · 27d
Cleared Dec 10, 1979
DEXIDE DIS. PREP SPONGE W/IDEX PATIENT P
K792273 · Dexide, Inc.
GEC · Brush, Scrub, Operating-room · 27d
Cleared Dec 10, 1979
BIPOLAR FORCEPS
K792365 · Concept, Inc.
JOS · Electrode, Electrosurgical · 17d
Cleared Dec 06, 1979
ARM SHIELD FOR ANESTHESIA
K792147 · Medical Innovations Corp.
BTX · Board, Arm (with Cover), Sterile · 45d
Cleared Dec 06, 1979
XOMED MICROSURGERY BACKGROUND
K792330 · Xomed, Inc.
· 17d
Cleared Dec 06, 1979
DAVOL/SIMON DERMATOME
K792332 · Davol, Inc.
GFD · Dermatome · 17d
Cleared Dec 06, 1979
HEMOSPENSER CARTRIDGE CAT. NO. 523500-
K792378 · Edward Weck, Inc.
GDO · Applier, Surgical, Clip · 10d
Cleared Nov 30, 1979
CASTROVIEJO VASCULAR NEEDLEHOLDER 538425
K792309 · Edward Weck, Inc.
GEN · Forceps, General & Plastic Surgery · 14d
Cleared Nov 27, 1979
USHER'S MARLEX TUBULAR MESH
K792281 · Davol, Inc.
FTL · Mesh, Surgical, Polymeric · 14d
Cleared Nov 27, 1979
A.D.E. ASPEN DISPERSIVE ELECTRODE
K792315 · Zimmer, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 11d
Cleared Nov 16, 1979
HYDRON BURN DRESSING FIELD KIT
K791865 · National Patent Development Corp.
KMF · Bandage, Liquid · 56d
Cleared Nov 16, 1979
SAFE RETURN COT. #9675 & CONNECTOR ADAPT
K792044 · Concept, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 35d

Looking for a specific general & plastic surgery device? Search by device name, K-number or manufacturer.

Search all General & Plastic Surgery 510(k) devices

Filter by Product Code

All categories 14317 GEX Powered Laser Surgical Instrument 2427 GEI Electrosurgical, Cutting & Coagulation & Accessories 1933 GCJ Laparoscope, General & Plastic Surgery 1130 FRO Dressing, Wound, Drug 591 FTL Mesh, Surgical, Polymeric 324 GDW Staple, Implantable 267 GEH Unit, Cryosurgical, Accessories 216 OMP Negative Pressure Wound Therapy Powered Suction Pump 214 KGN Wound Dressing With Animal-derived Material(s) 177 OHT Light Based Over-the-counter Hair Removal 166 GAT Suture, Nonabsorbable, Synthetic, Polyethylene 164 NAY System, Surgical, Computer Controlled Instrument 164 OHS Light Based Over The Counter Wrinkle Reduction 161 KMF Bandage, Liquid 157 EFQ Gauze/sponge, Internal 157