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
14018 General & Plastic Surgery devices
8126–8150 of 14018
Cleared Sep 06, 2001
VERASTEP
K012539 · United States Surgical, A Division of Tyco Healthc
GCJ · Laparoscope, General & Plastic Surgery · 30d
Cleared Sep 05, 2001
AMS SOFT-TISSUE APPROXIMATION SYSTEM
K012342 · American Medical Systems, Inc.
FZP · Clip, Implantable · 43d
Cleared Sep 04, 2001
ES-2000 SHAPE SELECT ELECTROSURGICAL SCALPEL
K012799 · Senorx, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 14d
Cleared Aug 30, 2001
ATRICURE BIPOLAR COAGULATION SYSTEM
K011722 · AtriCure, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 87d
Cleared Aug 30, 2001
PALOMAR LC 100 DIODE LASER
K011747 · Palomar Medical Technologies, Inc.
GEX · Powered Laser Surgical Instrument · 86d
Cleared Aug 30, 2001
MODIFICATION TO:ENDIUS BIPOLAR SHEATH
K012488 · Endius, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 27d
Cleared Aug 22, 2001
RADIOGRAPHIC MARKERS
K011856 · Encore Orthopedics, Inc.
NEU · Marker, Radiographic, Implantable · 70d
Cleared Aug 22, 2001
ORTHO DEVELOPMENT ORION-I EMF SYSTEM
K012129 · Ortho Development Corp.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 44d
Cleared Aug 09, 2001
ENDOPATH NON-BLADED SOLID OBTURATOR TROCAR SYSTEM
K011538 · Ethicon Endo-Surgery, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 83d
Cleared Aug 01, 2001
AESCULAP, INC. SAFIL QUICK SYNTHETIC ABSORBABLE SURGICAL SUTURE
K011372 · Aesculap, Inc.
GAM · Suture, Absorbable, Synthetic, Polyglycolic Acid · 89d
Cleared Jul 31, 2001
SCALPFIX CLIP SYSTEM
K012219 · Aesculap, Inc.
HBO · Clip, Scalp · 15d
Cleared Jul 27, 2001
ALLIGER ULTRASONIC SURGICAL SYSTEM MODEL AUSS-5
K012028 · Misonix, Inc.
LFL · Instrument, Ultrasonic Surgical · 29d
Cleared Jul 24, 2001
INTUITIVE SURGICAL ULTRASONIC SHEARS
K011281 · Intuitive Surgical, Inc.
NAY · System, Surgical, Computer Controlled Instrument · 88d
Cleared Jul 19, 2001
ENTEC EVAC PLASMA WAND
K011279 · Arthrocare Corp.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 83d
Cleared Jul 19, 2001
ENDOPOUCH RETRIEVER
K011501 · Ethicon Endo-Surgery, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 64d
Cleared Jul 16, 2001
BIOPSY SITE MARKER
K011402 · Senorx, Inc.
FZP · Clip, Implantable · 70d
Cleared Jul 13, 2001
ENDOPATH NON-BLADED OBTURATOR TROCAR SYSTEM (5 MM)
K011257 · Ethicon Endo-Surgery, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 80d
Cleared Jul 13, 2001
MEDLINE GROUNDING PAD
K011515 · Medline Industries, Inc.
JOS · Electrode, Electrosurgical · 57d
Cleared Jul 10, 2001
MODULAR VALVE HANDLES FOR ADAPTABLE TUBES, MODEL 1298-XX-XX, 1295-XX-XX
K011997 · Pajunk GmbH
GCJ · Laparoscope, General & Plastic Surgery · 13d
Cleared Jul 09, 2001
CANDELA SPTL-1E PULSED DYE LASER
K011092 · Candela Corp.
GEX · Powered Laser Surgical Instrument · 90d
Cleared Jul 03, 2001
WATERLASE, MILLENNIUM
K011041 · Biolase Technology, Inc.
GEX · Powered Laser Surgical Instrument · 89d
Cleared Jun 29, 2001
AESCULAP, INC., MONOSYN SYNTHETIC ABSORBABLE SURGICAL SUTURE
K011375 · Aesculap, Inc.
GAM · Suture, Absorbable, Synthetic, Polyglycolic Acid · 56d
Cleared Jun 28, 2001
MODIFICATION TO KSEA ENDOTIP SYSTEM
K011359 · KARL STORZ Endoscopy-America, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 56d
Cleared Jun 22, 2001
AMS SLING FIXATION SYSTEM
K010990 · American Medical Systems, Inc.
GAW · Suture, Nonabsorbable, Synthetic, Polypropylene · 80d
Cleared Jun 19, 2001
ARTHROCARE CONTROLLER, MODEL H2000
K011634 · Arthrocare Corp.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 21d

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All categories 14018 GEX Powered Laser Surgical Instrument 2373 GEI Electrosurgical, Cutting & Coagulation & Accessories 1872 GCJ Laparoscope, General & Plastic Surgery 1113 FRO Dressing, Wound, Drug 574 FTL Mesh, Surgical, Polymeric 316 GDW Staple, Implantable 257 OMP Negative Pressure Wound Therapy Powered Suction Pump 211 GEH Unit, Cryosurgical, Accessories 211 KGN Wound Dressing With Animal-derived Material(s) 171 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 157 KMF Bandage, Liquid 155