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

18288
Total
18243
Cleared
138d
Avg (2y)
1976
Since
14060 General & Plastic Surgery devices
9201–9225 of 14060
Cleared Dec 22, 1997
ENDOCARE CRYOCARE CRYOSURGICAL SYSTEM
K973686 · Endocare, Inc.
GEH · Unit, Cryosurgical, Accessories · 87d
Cleared Dec 19, 1997
AESOP 3000 SYSTEM AND ACCESSORIES
K972699 · Computer Motion, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 154d
Cleared Dec 19, 1997
ERBIUM 2000 LASER FAMILY
K972915 · Phantom Technologies, Inc.
GEX · Powered Laser Surgical Instrument · 134d
Cleared Dec 19, 1997
VALLEY FORGE BIPOLAR BALL TIP ELECTRODE
K973554 · Valley Forge Scientific Corp.
JOS · Electrode, Electrosurgical · 91d
Cleared Dec 19, 1997
SCHWARTZ ELECTRO-OPTICS, INC. CRYSTALASE 1064/532 LASER SYSTEM
K973603 · Schwartz Electro-Optics, Inc.
GEX · Powered Laser Surgical Instrument · 88d
Cleared Dec 19, 1997
SOMNOPLASTY SYSTEM
K973618 · Somnus Medical Technologies, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 87d
Cleared Dec 18, 1997
BIPOLAR ARTHROSCOPIC PROBE, STRAIGHT, BIOPOLAR ARTHROSCOPIC PROBE, ANGLED, BIPOLAR ARTHROSCOPIC PROBE, STRAIGHT,
K973682 · Electroscope, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 83d
Cleared Dec 18, 1997
AQUA PATCH
K973693 · Pci Technology
MGQ · Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic · 83d
Cleared Dec 17, 1997
SUPERSKIN
K972081 · Medlogic Global Corp.
NEC · Bandage, Liquid, Skin Protectant · 197d
Cleared Dec 17, 1997
ULTRACELL SUCTION SPONGE
K972634 · Ultracell Medical Technologies, Inc.
GDY · Gauze/sponge, Internal, X-ray Detectable · 156d
Cleared Dec 17, 1997
PRE-VIEW CHOLANGIOGRAPHY CLAMP
K973621 · Nashville Surgical Instruments
GBZ · Catheter, Cholangiography · 85d
Cleared Dec 17, 1997
MINI FORCEPS WITH HF, 3.5MM
K973648 · Richard Wolf Medical Instruments Corp.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 83d
Cleared Dec 17, 1997
DUODERM EXTRA THIN CGF DRESSING
K973716 · Convatec, A Bristol-Myers Squibb Co.
FRO · Dressing, Wound, Drug · 79d
Cleared Dec 17, 1997
COMBIDERM ACD
K973717 · Convatec, A Bristol-Myers Squibb Co.
FRO · Dressing, Wound, Drug · 79d
Cleared Dec 17, 1997
DAPELLE HAIR REMOVER
K973773 · Wellquest Intl., Inc.
KCX · Epilator, High Frequency, Tweezer-type · 76d
Cleared Dec 16, 1997
ARAGO
K971118 · Premier Laser Systems, Inc.
GEX · Powered Laser Surgical Instrument · 270d
Cleared Dec 16, 1997
KENDALL CURITY PETROLATUM GAUZE
K973511 · Kendall Healthcare Products Co. Div.Of Tyco Health
FRO · Dressing, Wound, Drug · 90d
Cleared Dec 16, 1997
N-TERFACE
K973538 · Winfield Laboratories, Inc.
MGP · Dressing, Wound And Burn, Occlusive · 89d
Cleared Dec 15, 1997
KENDALL XEROFORM PETROLATUM DRESSING (6311,6312,6313,6314,6315,6316,6317)
K973507 · Kendall Healthcare Products Co. Div.Of Tyco Health
FRO · Dressing, Wound, Drug · 90d
Cleared Dec 11, 1997
GREATBATCH SCIENTIFIC MR COMPATIBLE LAPAROSCOPES AND OPERATING LAPAROSCOPES
K972280 · Wilson Greatbatch Technologies, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 176d
Cleared Dec 10, 1997
B.U.S. ENDOTRON
K972148 · Medicamat S.A.
LFL · Instrument, Ultrasonic Surgical · 184d
Cleared Dec 10, 1997
OSMOCYTE ISLAND WOUND DRESSING
K972150 · Procyte Corp.
KMF · Bandage, Liquid · 184d
Cleared Dec 10, 1997
OSMOCYTE RA WOUND DRESSING
K972329 · Procyte Corp.
KMF · Bandage, Liquid · 170d
Cleared Dec 10, 1997
INVOTEC CLEAN PAD
K973580 · Invotec International, Inc.
EFQ · Gauze/sponge, Internal · 82d
Cleared Dec 10, 1997
KENDALL CURITY NON-ADHERING DRESSING
K973619 · Kendall Healthcare Products Co. Div.Of Tyco Health
KMF · Bandage, Liquid · 78d

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All categories 14060 GEX Powered Laser Surgical Instrument 2377 GEI Electrosurgical, Cutting & Coagulation & Accessories 1878 GCJ Laparoscope, General & Plastic Surgery 1116 FRO Dressing, Wound, Drug 575 FTL Mesh, Surgical, Polymeric 316 GDW Staple, Implantable 260 GEH Unit, Cryosurgical, Accessories 213 OMP Negative Pressure Wound Therapy Powered Suction Pump 211 KGN Wound Dressing With Animal-derived Material(s) 172 NAY System, Surgical, Computer Controlled Instrument 163 OHT Light Based Over-the-counter Hair Removal 162 OHS Light Based Over The Counter Wrinkle Reduction 161 GAT Suture, Nonabsorbable, Synthetic, Polyethylene 158 EFQ Gauze/sponge, Internal 157 KMF Bandage, Liquid 155