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
3551–3575 of 4109
Cleared Apr 01, 1999
NOVAFIL** AND VASCUFIL** STERILE SYNTHETIC NON-ABSORBABLE SUTURES
K990952 · United States Surgical, A Division of Tyco Healthc
GAT · Suture, Nonabsorbable, Synthetic, Polyethylene · 10d
Cleared Apr 01, 1999
MAXON** STERILE, SYNTHETIC, ABSORBABLE SUTURE
K990951 · United States Surgical, A Division of Tyco Healthc
GAM · Suture, Absorbable, Synthetic, Polyglycolic Acid · 10d
Cleared Mar 22, 1999
DAFILON NONABSORBABLE POLYAMIDE SURGICAL SUTURE
K990090 · Aesculap, Inc.
GAR · Suture, Nonabsorbable, Synthetic, Polyamide · 70d
Cleared Mar 15, 1999
SILKAM NONABSORBABLE SILK SURGICAL SUTURE
K990089 · Aesculap, Inc.
GAP · Suture, Nonabsorbable, Silk · 63d
Cleared Mar 01, 1999
PRE-THREADED ENDOBUTTON
K984550 · Smith & Nephew, Inc.
GAT · Suture, Nonabsorbable, Synthetic, Polyethylene · 69d
Cleared Feb 23, 1999
MODIFICATION OF PROLENE (POLYPROPYLENE) HERNIA SYSTEM, NONABSORBABLE SYNTHETIC SURGICAL MESH
K984220 · Ethicon, Inc.
FTL · Mesh, Surgical, Polymeric · 90d
Cleared Feb 10, 1999
SYNTHOFIL NONABSORBABLE PET SURGICAL SUTURE
K990088 · Aesculap, Inc.
GAT · Suture, Nonabsorbable, Synthetic, Polyethylene · 30d
Cleared Feb 10, 1999
AUTO SUTURE SITE MARKER CLIP
K983400 · United States Surgical, A Division of Tyco Healthc
GDW · Staple, Implantable · 135d
Cleared Feb 01, 1999
AESCULAP XENON LIGHT SOURCE
K984124 · Aesculap, Inc.
FSS · Light, Surgical, Floor Standing · 75d
Cleared Jan 07, 1999
MODIFIED AUTO SUTURE*VCS** ANASTOMOTIC**CLIP CARTRIDGE
K984438 · United States Surgical, A Division of Tyco Healthc
FZP · Clip, Implantable · 24d
Cleared Dec 18, 1998
SYNTHES SYNMESH
K983766 · Synthes (Usa)
EZX · Mesh, Surgical, Metal · 53d
Cleared Dec 18, 1998
DCI ENDOSCOPE
K983363 · KARL STORZ Endoscopy-America, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 85d
Cleared Dec 16, 1998
AUTO SUTURE LAPAROSCOPES DEVICE
K983293 · United States Surgical, A Division of Tyco Healthc
GCJ · Laparoscope, General & Plastic Surgery · 86d
Cleared Dec 10, 1998
ALGISITE M
K983210 · Smith & Nephew, Inc.
KMF · Bandage, Liquid · 87d
Cleared Nov 06, 1998
MESH, SURGICAL, POLYMERIC
K982575 · United States Surgical, A Division of Tyco Healthc
FTL · Mesh, Surgical, Polymeric · 105d
Cleared Oct 26, 1998
3M TEGASORB HYDROCOLLOID DRESSING
K982893 · 3M Company
KMF · Bandage, Liquid · 70d
Cleared Oct 26, 1998
3M TEGASORB THIN HYDROCOLLOID DRESSING
K982892 · 3M Company
KMF · Bandage, Liquid · 70d
Cleared Sep 30, 1998
AESCULAP NEEDLESCOPIC INSTRUMENT SYSTEM
K982623 · Aesculap, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 64d
Cleared Sep 25, 1998
DEPUY ORTHOTECH RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT
K982330 · Depuy, Inc.
FTM · Mesh, Surgical · 85d
Cleared Sep 03, 1998
ELECTROSURGICAL UNIT (ESU) (115 VOLT) MODEL 4810, ELECTROSURGICAL UNIT (ESU) (230 VOLT) MODEL 4811, INSTRUMENT CABLE, 19
K981981 · Boston Scientific Corp
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 90d
Cleared Jul 31, 1998
CICANET WOUND CONTACT LAYER DRESSING - 2 X 3 IN. MODEL 59100600, CICANET WOUND CONTACT LAYER DRESSING - 4 X 5 IN. MODEL0
K981713 · Smith & Nephew, Inc.
MGP · Dressing, Wound And Burn, Occlusive · 77d
Cleared Jul 17, 1998
KODAK PRO-MEDICAL DIGITAL CAMERA SYSTEM
K973430 · Eastman Kodak Company
GCJ · Laparoscope, General & Plastic Surgery · 310d
Cleared Jul 13, 1998
POWERSTAR BIPOLAR SCISSORS
K981361 · Ethicon, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 90d
Cleared Jul 09, 1998
ENDOPOUCH PRO SPECIMEN RETRIEVAL BAG
K981579 · Ethicon, Inc.
MDM · Instrument, Manual, Surgical, General Use · 66d
Cleared Jun 25, 1998
POLYSORB SUTURE
K981935 · United States Surgical, A Division of Tyco Healthc
GAM · Suture, Absorbable, Synthetic, Polyglycolic Acid · 23d

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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