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
13897 General & Plastic Surgery devices
6926–6950 of 13897
Cleared Jul 19, 2006
HIGHLAND BEAM DELIVERY SYSTEM, MODEL 3-099-002-00-00
K061909 · Omniguide, Inc.
GEX · Powered Laser Surgical Instrument · 13d
Cleared Jul 19, 2006
QUIKCLOT 1ST RESPONSE & QUIKCLOT ACS+
K061767 · Z-Medica Corporation
QSY · Hemostatic Wound Dressing Without Thrombin Or Other Biologics · 26d
Cleared Jul 19, 2006
OASIS WOUND MATRIX
K061711 · Cook Biotech, Inc.
KGN · Wound Dressing With Animal-derived Material(s) · 30d
Cleared Jul 19, 2006
OPTILENE MESH
K061704 · Aesculap, Inc.
FTL · Mesh, Surgical, Polymeric · 33d
Cleared Jul 19, 2006
TROKAMED GMBH ENDOSCOPES AND ACCESSORIES
K060233 · Trokamed GmbH
GCJ · Laparoscope, General & Plastic Surgery · 170d
Cleared Jul 18, 2006
SANARUS VISICA TREATMENT SYSTEM
K061510 · Sanarus Medical, Inc.
GEH · Unit, Cryosurgical, Accessories · 47d
Cleared Jul 18, 2006
BOVIE INAFLASH SUTURE REMOVER HANDLE,CHARGER,HANDLE AND CHARGER,KIT,BATTERY PACK
K061307 · Aaron Medical Industries
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 69d
Cleared Jul 18, 2006
COMPOUND W FREEZE OFF WART REMOVAL SYSTEM
K060859 · OraSure Technologies, Inc.
GEH · Unit, Cryosurgical, Accessories · 112d
Cleared Jul 17, 2006
SURGICAL MESH SYSTEM
K053215 · Nuvasive, Inc.
FTL · Mesh, Surgical, Polymeric · 242d
Cleared Jul 14, 2006
SYNERGY HIP SYSTEM
K061066 · Smith & Nephew, Inc.
LZO · Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented · 88d
Cleared Jul 14, 2006
PDS PLUS ANTIBACTERIAL SUTURE
K061037 · Ethicon, Inc.
NEW · Suture, Surgical, Absorbable, Polydioxanone · 91d
Cleared Jul 14, 2006
TYRX ANTIMICROBIAL MESH
K053656 · Tyrx Pharma, Inc.
FTL · Mesh, Surgical, Polymeric · 196d
Cleared Jul 12, 2006
TROKAMED GMBH ELECTROSURGICAL INSTRUMENTS & ACCESSORIES
K060232 · Trokamed GmbH
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 163d
Cleared Jul 11, 2006
BOEHRINGER LABORATORIES SUCTION PUMP SYSTEM
K061788 · Boehringer Laboratories
OMP · Negative Pressure Wound Therapy Powered Suction Pump · 15d
Cleared Jul 11, 2006
SIMEX SUCTION PUMP, MODELS AC20, AC20K, AC30, DC20, DC30 AND DC30S
K061133 · Novaspine, LLC
BTA · Pump, Portable, Aspiration (manual Or Powered) · 78d
Cleared Jul 10, 2006
DENLASER 800 PLUS
K061366 · CAO Group, Inc.
GEX · Powered Laser Surgical Instrument · 55d
Cleared Jul 07, 2006
HEMCON DENTAL DRESSING, 1 DRESSING, 4 DRESSING, 1 DRESSING, BOX OF 12, 4 DRESSING, BOX OF 12
K060363 · Hemcon, Inc.
OLR · Oral Wound Dressing · 144d
Cleared Jul 06, 2006
LUMENIS ONE FAMILY OF SYSTEMS
K060448 · Lumenis, Ltd.
GEX · Powered Laser Surgical Instrument · 135d
Cleared Jul 05, 2006
COLLAWOUND DRESSING
K061474 · Collamatrix Co., Inc.
KGN · Wound Dressing With Animal-derived Material(s) · 36d
Cleared Jul 05, 2006
ANCHOR BAND SUTURING SYSTEM, MODEL SR-AB
K061386 · Anulex Technologies, Inc.
GAT · Suture, Nonabsorbable, Synthetic, Polyethylene · 48d
Cleared Jul 05, 2006
OCULASE MD
K052354 · Biolase Technology, Inc.
GEX · Powered Laser Surgical Instrument · 310d
Cleared Jul 03, 2006
SMOOTHSHAPES
K061603 · Biocellulase, Inc.
NUV · Massager, Vacuum, Light Induced Heating · 25d
Cleared Jul 03, 2006
STATARIUS, MODEL 001 003
K061292 · Kinetic Surgical, LLC
GCJ · Laparoscope, General & Plastic Surgery · 55d
Cleared Jul 03, 2006
ENDOPATH ENDOCUTTER 60 ENDOSCOPIC LINEAR CUTTER, MODELS EC60, SC60 AND LONG60 AND ENDOPATH & PROXIMATE LINEAR CUTTERS
K061156 · Ethicon Endo-Surgery, Inc.
GDW · Staple, Implantable · 68d
Cleared Jul 03, 2006
TT101, MODELS TT 101-1,-2,-3,-4,-5,-6,-7,-8
K061060 · Tissue Technologies Holdings, LLC
FRO · Dressing, Wound, Drug · 77d

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All categories 13897 GEX Powered Laser Surgical Instrument 2361 GEI Electrosurgical, Cutting & Coagulation & Accessories 1854 GCJ Laparoscope, General & Plastic Surgery 1099 FRO Dressing, Wound, Drug 556 FTL Mesh, Surgical, Polymeric 313 GDW Staple, Implantable 252 GEH Unit, Cryosurgical, Accessories 210 OMP Negative Pressure Wound Therapy Powered Suction Pump 207 KGN Wound Dressing With Animal-derived Material(s) 169 NAY System, Surgical, Computer Controlled Instrument 163 OHT Light Based Over-the-counter Hair Removal 162 OHS Light Based Over The Counter Wrinkle Reduction 159 EFQ Gauze/sponge, Internal 157 GAT Suture, Nonabsorbable, Synthetic, Polyethylene 155 KMF Bandage, Liquid 155