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

18201
Total
18157
Cleared
138d
Avg (2y)
1976
Since
4109 General & Plastic Surgery devices
3576–3600 of 4109
Cleared Jun 22, 1998
SOLOSITE GEL CONFORMABLE DRESSING
K981150 · Smith & Nephew, Inc.
MGQ · Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic · 83d
Cleared May 19, 1998
SMITH & NEPHEW DYONICS ENDOSCOPES AND ACCESSORIES
K980604 · Smith & Nephew, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 91d
Cleared May 11, 1998
SOFSILK SUTURE
K981128 · United States Surgical, A Division of Tyco Healthc
GAP · Suture, Nonabsorbable, Silk · 42d
Cleared May 11, 1998
SAFIL SYNTHETIC ABSORBABLE SURGICAL SUTURE
K980704 · Aesculap, Inc.
GAM · Suture, Absorbable, Synthetic, Polyglycolic Acid · 77d
Cleared May 04, 1998
PREMILENE NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE
K980703 · Aesculap, Inc.
GAW · Suture, Nonabsorbable, Synthetic, Polypropylene · 70d
Cleared Apr 25, 1998
AUTO SUTURE*ENDOSTITCH* II** SUTURE APPLIER
K972911 · United States Surgical, A Division of Tyco Healthc
GAT · Suture, Nonabsorbable, Synthetic, Polyethylene · 261d
Cleared Apr 01, 1998
ENDOBUTTON CONTINUOUS LOOP
K980155 · Smith & Nephew, Inc.
GAT · Suture, Nonabsorbable, Synthetic, Polyethylene · 75d
Cleared Mar 27, 1998
SOFSILK SUTURE
K980124 · United States Surgical, A Division of Tyco Healthc
GAP · Suture, Nonabsorbable, Silk · 72d
Cleared Feb 27, 1998
KSEA ENDOTIP SYSTEM
K973909 · KARL STORZ Endoscopy-America, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 136d
Cleared Feb 13, 1998
PANACRYL
K974299 · Ethicon, Inc.
GAM · Suture, Absorbable, Synthetic, Polyglycolic Acid · 88d
Cleared Jan 12, 1998
INTERCEPTRE LAPAROSCOPIC INSTRUMENTS
K974592 · Smith & Nephew, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 34d
Cleared Dec 05, 1997
ETHICON NON-STICK BIPOLAR FORCEPS
K973384 · Ethicon, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 88d
Cleared Nov 25, 1997
STING SKIN PREP WIPE(59420600)/STING SKIN PREP SWAB (59420700)
K973228 · Smith & Nephew, Inc.
KMF · Bandage, Liquid · 90d
Cleared Oct 29, 1997
POWERSTAR BIPOLAR SCISSORS
K973173 · Ethicon, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 65d
Cleared Oct 24, 1997
DIGITAL 3-CHIP COLOR VIDEO CAMERA, ILLUMINATORS, VIDEO COMPONENTS AND ACCESSORIES
K972471 · Smith & Nephew, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 115d
Cleared Oct 24, 1997
AUTO SUTURE BONE WAX
K971680 · United States Surgical, A Division of Tyco Healthc
MTJ · Wax, Bone · 170d
Cleared Sep 19, 1997
MINISITE*BIPOLAR FORCEPS** DEVICE
K972415 · United States Surgical, A Division of Tyco Healthc
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 84d
Cleared Sep 10, 1997
PROLENE POLYPROPYLENE MESH HERNIA DEVICE NONABSORBABLE SYNTHETIC SURGICAL MESH
K972412 · Ethicon, Inc.
FTL · Mesh, Surgical, Polymeric · 76d
Cleared Aug 27, 1997
KARL STORZ MONOPOLAR COAGULATING ELECTRODES/ KARL STORZ MONOPOLAR COAGULATING NEEDLE ELECTRODES
K972497 · KARL STORZ Endoscopy-America, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 55d
Cleared Aug 12, 1997
SMITH & NEPHEW IMAGES ENDOSCOPES AND ACCESSORIES
K971850 · Smith & Nephew, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 84d
Cleared Aug 11, 1997
MVM 3.3 MM MICROENDOSCOPE
K972504 · KARL STORZ Endoscopy-America, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 39d
Cleared Jul 30, 1997
IMPLANTABLE CLIP
K970793 · United States Surgical, A Division of Tyco Healthc
FZP · Clip, Implantable · 148d
Cleared Jul 18, 1997
3M UNIVERSAL ELECTROSURGICAL PAD SPLIT/SOLID(9130&9160)
K971446 · 3M Company
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 88d
Cleared Jul 18, 1997
AESCULAP JET IRRIGATION SYSTEM
K971310 · Aesculap, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 101d
Cleared Jul 01, 1997
ULTRASONIC HAND INSTRUMENTS
K971861 · United States Surgical, A Division of Tyco Healthc
LFL · Instrument, Ultrasonic Surgical · 42d

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 4109 GEI Electrosurgical, Cutting & Coagulation & Accessories 539 GEX Powered Laser Surgical Instrument 498 GCJ Laparoscope, General & Plastic Surgery 334 FRO Dressing, Wound, Drug 163 OHT Light Based Over-the-counter Hair Removal 142 OHS Light Based Over The Counter Wrinkle Reduction 118 GDW Staple, Implantable 107 NAY System, Surgical, Computer Controlled Instrument 99 FTL Mesh, Surgical, Polymeric 95 OMP Negative Pressure Wound Therapy Powered Suction Pump 93 KGN Wound Dressing With Animal-derived Material(s) 74 OAP Laser, Comb, Hair 72 GAT Suture, Nonabsorbable, Synthetic, Polyethylene 71 GAM Suture, Absorbable, Synthetic, Polyglycolic Acid 62 GEH Unit, Cryosurgical, Accessories 62