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
13800 General & Plastic Surgery devices
5126–5150 of 13800
Cleared Oct 25, 2012
ENSEAL TRIO TISSUE SEALING DEVICE
K123141 · Ethicon Endo-Surgery, LLC
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 20d
Cleared Oct 25, 2012
SPIDER SURGICAL INSTRUMENTS, FLEXIBLE MONOPOLAR GRASPER WAVY RATCHETED, SPIDER SURGICAL INSTRUMENTS, FLEXIBLE MONOPOLAR
K122299 · Transenterix, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 86d
Cleared Oct 25, 2012
INTUITIVE SURGICAL ONSITE FOR DA VINCI SURGICAL SYSTEMS
K121921 · Intuitive Surgical, Inc.
NAY · System, Surgical, Computer Controlled Instrument · 115d
Cleared Oct 23, 2012
ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE
K123109 · Covidien
GDW · Staple, Implantable · 19d
Cleared Oct 23, 2012
IPULSE SMOOTHSKIN HAIR REMOVAL SYSTEM
K122280 · Cyden Limited
OHT · Light Based Over-the-counter Hair Removal · 85d
Cleared Oct 23, 2012
MEDRANGE ELECTROSURGICAL EXPANSION SYSTEM
K122092 · Medrange Corporation
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 99d
Cleared Oct 22, 2012
QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN
K122898 · Surgical Specialties Corp. Dba Angiotech
GAM · Suture, Absorbable, Synthetic, Polyglycolic Acid · 31d
Cleared Oct 22, 2012
PHASIX PLUG AND PATCH
K120728 · C.R. Bard, Inc.
OWT · Mesh, Surgical, Absorbable, Abdominal Hernia · 227d
Cleared Oct 18, 2012
SMITH & NEPHEW ULTRA FAST-FIX MENISCAL REPAIR SYSTEM, SMITH & NEPHEW ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEM, SMITH & N
K121861 · Smith & Nephew, Inc.
GAT · Suture, Nonabsorbable, Synthetic, Polyethylene · 114d
Not Cleared Oct 18, 2012
VIRULITE COLD SORE MACHINE
DEN090012 · Virulite, LLC
OKJ · Light Based Treatment For Cold Sores Herpes Simplex Virus-1 · 1206d
Cleared Oct 17, 2012
ENDOWRIST STAPLER SYSTEM
K113706 · Intuitive Surgical, Inc.
NAY · System, Surgical, Computer Controlled Instrument · 306d
Cleared Oct 16, 2012
ACCUMESH DEPLOYMENT SYSTEM
K123066 · Covidien, LLC
ORQ · Mesh, Surgical, Deployer · 15d
Cleared Oct 12, 2012
ME HAIR2GO
K121598 · Syneron Medical, Ltd.
ONF · Powered Light Based Non-laser Surgical Instrument With Thermal Effect · 134d
Cleared Oct 11, 2012
PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, PREVENA CUSTOMIZABLE DRESSING KIT
K121883 · Kci USA, Inc. (Kinetic Concepts, Inc.)
OMP · Negative Pressure Wound Therapy Powered Suction Pump · 105d
Cleared Oct 11, 2012
WECK REUSABLE OBTURATOR
K121796 · Teleflexmedical, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 114d
Cleared Oct 05, 2012
ABTHERA OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM
K120499 · Kci USA, Inc. (Kinetic Concepts, Inc.)
OMP · Negative Pressure Wound Therapy Powered Suction Pump · 227d
Cleared Oct 05, 2012
REPROCESSED SURGICAL ELECTRIC INSTRUMENT
K120040 · Sterilmed, Inc.
NUJ · Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed · 274d
Cleared Oct 02, 2012
PENUMBRA PUMP MAX (110VAC), PENUMBRA PUMP MAX (230VAC), PENUMBAR PUMP MAX CANISTER/TUBING
K122756 · Penumbra, Inc.
JCX · Apparatus, Suction, Ward Use, Portable, Ac-powered · 25d
Cleared Oct 02, 2012
EPIX IRRIGATION PUMP, EPIX SUCTION IRRIGATION TUBING SET
K122619 · Applied Medical
BTA · Pump, Portable, Aspiration (manual Or Powered) · 35d
Cleared Oct 02, 2012
ULTHERA SYSTEM
K121700 · Ulthera, Inc.
OHV · Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption · 117d
Cleared Oct 01, 2012
ENDOPATH XCEL BLADELESS TROCAR WITH OPTIVIEW TECHNOLOGY ENDOPATH XCEL BLUNT TIP TROCAR WITH OPTIVIEW TECHNOLOGY ENDOPATH
K122511 · Ethicon Endo-Surgery, LLC
GCJ · Laparoscope, General & Plastic Surgery · 45d
Cleared Oct 01, 2012
SMARTLUX
K120460 · Medmix Co., Ltd.
GEX · Powered Laser Surgical Instrument · 229d
Cleared Oct 01, 2012
SERF ABLATION SYSTEM SERF ABLATION NEEDLE
K120116 · Thermedical
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 262d
Cleared Oct 01, 2012
INVIA MOTION NEGATIVE PRESSURE WOUND THERAPY SYSTEM
K113678 · Medela AG
OMP · Negative Pressure Wound Therapy Powered Suction Pump · 292d
Cleared Sep 28, 2012
EPIC 10
K121286 · Biolase Technology, Inc.
GEX · Powered Laser Surgical Instrument · 151d

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All categories 13800 GEX Powered Laser Surgical Instrument 2350 GEI Electrosurgical, Cutting & Coagulation & Accessories 1839 GCJ Laparoscope, General & Plastic Surgery 1088 FRO Dressing, Wound, Drug 540 FTL Mesh, Surgical, Polymeric 307 GDW Staple, Implantable 251 GEH Unit, Cryosurgical, Accessories 209 OMP Negative Pressure Wound Therapy Powered Suction Pump 207 KGN Wound Dressing With Animal-derived Material(s) 166 NAY System, Surgical, Computer Controlled Instrument 163 OHT Light Based Over-the-counter Hair Removal 162 OHS Light Based Over The Counter Wrinkle Reduction 158 EFQ Gauze/sponge, Internal 157 KMF Bandage, Liquid 154 GAT Suture, Nonabsorbable, Synthetic, Polyethylene 151