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

18256
Total
18211
Cleared
136d
Avg (2y)
1976
Since
7655 General & Plastic Surgery devices
4251–4275 of 7655
Cleared May 17, 2004
RESTORE WOUND CLEANSER
K040779 · Hollister, Inc.
KMF · Bandage, Liquid · 52d
Cleared May 17, 2004
CONTREET FOAM CAVITY DRESSING WITH SILVER, MODEL 9628 (2X4 IN.)
K033869 · Coloplast Corp.
FRO · Dressing, Wound, Drug · 157d
Cleared May 13, 2004
MODIFICATION TO SELF-DRILLING RADIOGRAPHIC MARKERS
K040990 · Walter Lorenz Surgical, Inc.
NEU · Marker, Radiographic, Implantable · 27d
Cleared May 10, 2004
COLLAGEN WOUND DRESSING - ORAL
K040403 · Collagen Matrix, Inc.
KGN · Wound Dressing With Animal-derived Material(s) · 83d
Cleared May 05, 2004
INTUITIVE SURGICAL ENDOPASS ENDOSCOPIC DELIVERY INSTRUMENT, MODEL P/N 400170
K040948 · Intuitive Surgical, Inc.
NAY · System, Surgical, Computer Controlled Instrument · 23d
Cleared Apr 30, 2004
SMARTLITE D FREQUENCY DOUBLED ND:YAG LASER
K040289 · Cynosure, Inc.
GEX · Powered Laser Surgical Instrument · 84d
Cleared Apr 29, 2004
MODIFICATION TO PARIETEX COMPOSITE (PCO) MESH
K040998 · Sofradim Production
FTL · Mesh, Surgical, Polymeric · 10d
Cleared Apr 28, 2004
CONCERTO BIPOLAR NEEDLE ELECTRODE
K040785 · Boston Scientific Corp
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 30d
Cleared Apr 22, 2004
RESOLUTION HEMOSTASIS CLIPPING DEVICE
K040148 · Boston Scientific Corp
MCH · Clip, Hemostatic · 90d
Cleared Apr 01, 2004
ULTRAPRO MESH
K033337 · Ethicon, Inc.
FTL · Mesh, Surgical, Polymeric · 167d
Cleared Mar 30, 2004
GEMINI SURGICAL LASER SYSTEM & ACCESSORIES
K034011 · Laserscope
GEX · Powered Laser Surgical Instrument · 97d
Cleared Mar 25, 2004
TENDERWET ACTIVE
K040517 · Medline Industries, Inc.
MGQ · Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic · 27d
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 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 15, 2004
FORCE FIBER BLUE CO-BRAIDED POLYETHYLENE NONABSORBABLE SURGICAL SUTURE
K040472 · Teleflex Medical
GAT · Suture, Nonabsorbable, Synthetic, Polyethylene · 20d
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 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 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
SMITH & NEPHEW ELECTROTHERMAL 20S SPINE GENERATOR, MODEL 7209975
K033981 · Smith & Nephew, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 64d
Cleared Feb 25, 2004
COLORADO MICRODISSECTION NEEDLE
K033232 · Stryker Corp.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 142d
Cleared Feb 24, 2004
COBRA SURGICAL PROBE
K040219 · Boston Scientific Corp
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 22d
Cleared Feb 18, 2004
COBRA ADHERE SURGICAL SYSTEM, MODEL M00415977C0
K040104 · Boston Scientific Corp
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 29d
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 04, 2004
CURVED CUTTER STAPLER, MODELS CS40B, CS40G
K040038 · Ethicon Endo-Surgery, Inc.
GDW · Staple, Implantable · 27d

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All categories 7655 GEX Powered Laser Surgical Instrument 1148 GEI Electrosurgical, Cutting & Coagulation & Accessories 1106 GCJ Laparoscope, General & Plastic Surgery 682 FRO Dressing, Wound, Drug 216 FTL Mesh, Surgical, Polymeric 186 GDW Staple, Implantable 159 NAY System, Surgical, Computer Controlled Instrument 158 OHT Light Based Over-the-counter Hair Removal 142 OHS Light Based Over The Counter Wrinkle Reduction 120 OMP Negative Pressure Wound Therapy Powered Suction Pump 101 FZP Clip, Implantable 100 GAT Suture, Nonabsorbable, Synthetic, Polyethylene 93 LFL Instrument, Ultrasonic Surgical 85 KGN Wound Dressing With Animal-derived Material(s) 85 GEH Unit, Cryosurgical, Accessories 78