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
13978 General & Plastic Surgery devices
7651–7675 of 13978
Cleared Mar 19, 2004
CERALAS D 980 DIODE LASER SYSTEM, MODELS D15, D25, D50
K032863 · Biolitec, Inc.
GEX · Powered Laser Surgical Instrument · 189d
Cleared Mar 19, 2004
CERALAS D 810 DIODE LASER SYSTEM, MODEL D15
K032864 · Biolitec, Inc.
GEX · Powered Laser Surgical Instrument · 189d
Cleared Mar 17, 2004
TOPSEAL HEMOSTATIC DRESSING, MODEL 11150
K033291 · Radi Medical Systems AB
QSY · Hemostatic Wound Dressing Without Thrombin Or Other Biologics · 155d
Cleared Mar 17, 2004
VASCULAR SOLUTIONS D-STAT DRY 3X3 HEMOSTATIC PAD
K040510 · Vascular Solutions, Inc.
QSX · Hemostatic Wound Dressing With Thrombin Or Other Biologics · 19d
Cleared Mar 17, 2004
MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING
K040558 · Collagen Matrix, Inc.
KGN · Wound Dressing With Animal-derived Material(s) · 14d
Cleared Mar 15, 2004
FORCE FIBER BLUE CO-BRAIDED POLYETHYLENE NONABSORBABLE SURGICAL SUTURE
K040472 · Teleflex Medical
GAT · Suture, Nonabsorbable, Synthetic, Polyethylene · 20d
Cleared Mar 10, 2004
STARLUX PULSED LIGHT SYSTEM
K033549 · Palomar Medical Products, Inc.
GEX · Powered Laser Surgical Instrument · 119d
Cleared Mar 09, 2004
PROFILE 1320 LASER SYSTEM
K032459 · Sciton, Inc
GEX · Powered Laser Surgical Instrument · 211d
Cleared Mar 05, 2004
PAJUNK MODULAR HANDLE INSTRUMENTS
K033249 · Pajunk GmbH
GCJ · Laparoscope, General & Plastic Surgery · 150d
Cleared Mar 01, 2004
BARD SOFT MESH, MODELS 0117001, 0117002, 0117003, 0117004, 0117005, 0117006, 0117007
K033814 · C.R. Bard, Inc.
FTL · Mesh, Surgical, Polymeric · 83d
Cleared Mar 01, 2004
ARTHROCARE CONTROLLER, CABLE, FOOT CONTROL, POWER CORD, WANDS, MODELS H0970-02, H2000-04, H2000-05, H0970-06
K040338 · Arthrocare Corp.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 19d
Cleared Feb 27, 2004
MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING
K040211 · Collagen Matrix, Inc.
KGN · Wound Dressing With Animal-derived Material(s) · 28d
Cleared Feb 25, 2004
COLORADO MICRODISSECTION NEEDLE
K033232 · Stryker Corp.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 142d
Cleared Feb 25, 2004
SMITH & NEPHEW ELECTROTHERMAL 20S SPINE GENERATOR, MODEL 7209975
K033981 · Smith & Nephew, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 64d
Cleared Feb 24, 2004
COBRA SURGICAL PROBE
K040219 · Boston Scientific Corp
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 22d
Cleared Feb 18, 2004
SIS PLASTIC SURGERY MATRIX
K034039 · Cook Biotech, Inc.
FTM · Mesh, Surgical · 51d
Cleared Feb 18, 2004
COBRA ADHERE SURGICAL SYSTEM, MODEL M00415977C0
K040104 · Boston Scientific Corp
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 29d
Cleared Feb 12, 2004
MAXBRAID POLYESTER PLUS AND POLYETHYLENE PLUS SUTURE
K033718 · Arthrotek, Inc.
GAT · Suture, Nonabsorbable, Synthetic, Polyethylene · 78d
Cleared Feb 12, 2004
VASCULAR SOLUTIONS D-STAT DRY HEMOSTATIC BANDAGE, THE D-STAT RADIAL HEMOSTATIC BAND AND THE D-STAT 2 DRY HEMOSTATIC
K040118 · Vascular Solutions, Inc.
QSX · Hemostatic Wound Dressing With Thrombin Or Other Biologics · 23d
Cleared Feb 09, 2004
APOGEE ELITE
K034030 · Cynosure, Inc.
GEX · Powered Laser Surgical Instrument · 42d
Cleared Feb 05, 2004
HEMOSTATIX, MODEL 2400Z THERMAL SCALPEL SYSTEM
K033089 · Gyrus Ent LLC
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 129d
Cleared Feb 04, 2004
MINIMALLY INVASIVE SOLUTIONS OSTEOTOMY GUIDE INSTRUMENT
K033652 · Zimmer, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 76d
Cleared Feb 04, 2004
THERMAGE THERMACOOL SYSTEM
K033942 · Thermage, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 47d
Cleared Feb 04, 2004
SURGASSIST CIRCULAR STAPLER DIGITAL LOADING UNITS - 29 MM, MODEL CS29
K040024 · Power Medical Interventions, Inc.
GDW · Staple, Implantable · 28d
Cleared Feb 04, 2004
CURVED CUTTER STAPLER, MODELS CS40B, CS40G
K040038 · Ethicon Endo-Surgery, Inc.
GDW · Staple, Implantable · 27d

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All categories 13978 GEX Powered Laser Surgical Instrument 2370 GEI Electrosurgical, Cutting & Coagulation & Accessories 1864 GCJ Laparoscope, General & Plastic Surgery 1112 FRO Dressing, Wound, Drug 565 FTL Mesh, Surgical, Polymeric 316 GDW Staple, Implantable 256 GEH Unit, Cryosurgical, Accessories 210 OMP Negative Pressure Wound Therapy Powered Suction Pump 209 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 156 KMF Bandage, Liquid 155