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
137d
Avg (2y)
1976
Since
7713 General & Plastic Surgery devices
Cleared
Jun 25, 1992
LASERSCOPE'S DISPOSABLE LAPAROSTAT W/ FIBER DIVER
GEX
Powered Laser Surgical Instrument
94d
Cleared
Jun 24, 1992
EXCEL DUOPAULSE MODEL 2000
GEX
Powered Laser Surgical Instrument
188d
Cleared
Jun 19, 1992
ULTRA-CORE BIOPSY NEEDLES
DWO
Needle, Biopsy, Cardiovascular
87d
Cleared
Jun 18, 1992
ULTRALINE STERILE DISPOSABLE FIBER
GEX
Powered Laser Surgical Instrument
64d
Cleared
Jun 15, 1992
ND
GEX
Powered Laser Surgical Instrument
185d
Cleared
Jun 12, 1992
CUSA SYSTEM 200C AND 200T ULTRASONIC ASPIRATOR
LFL
Instrument, Ultrasonic Surgical
88d
Cleared
Jun 11, 1992
AUTO SUTURE(R) ARTICULATING ENDOSCOPIC CLAMP
GET
Motor, Surgical Instrument, Pneumatic Powered
233d
Cleared
Jun 11, 1992
AUTO SUTURE(R) ARTICULATING ENDOSCOPIC SCISSORS
GCJ
Laparoscope, General & Plastic Surgery
233d
Cleared
Jun 08, 1992
SHARPLAN CO2 SURG. LASER, MO. 1039 SURGICENTER 40
GEX
Powered Laser Surgical Instrument
90d
Cleared
Jun 05, 1992
DAVOL ENDO-FLO LASER PROBE AND ACCESSORIES
GEX
Powered Laser Surgical Instrument
114d
Cleared
Jun 05, 1992
CANDELA PLTL-1 LASER SYSTEM: PIGMENTED LESION LAS.
GEX
Powered Laser Surgical Instrument
150d
Cleared
Jun 04, 1992
MULTI USE LAPAROSCOPY ELECTROSURGICAL INSTRUMENT
GEI
Electrosurgical, Cutting & Coagulation & Accessories
199d
Cleared
May 29, 1992
STERILE,DISPOSABLE EYE DRESSING
HMP
Pad, Eye
71d
Cleared
May 29, 1992
ETHICON LIGACLIP ENDO LD APPLIER/DIVIDER
FZP
Clip, Implantable
94d
Cleared
May 29, 1992
PRE-CUT TRACHEOSTOMY DRESSING STERILE, DISPOSABLE
NAB
Gauze / Sponge,nonresorbable For External Use
128d
Cleared
May 29, 1992
PROCEL BURN COVER
MGP
Dressing, Wound And Burn, Occlusive
158d
Cleared
May 29, 1992
COATED SURGIPRO(TM) POLYPROPYLENE SURGICAL MESH
FTL
Mesh, Surgical, Polymeric
171d
Cleared
May 28, 1992
COMFEEL CONTOUR DRESSING
KMF
Bandage, Liquid
90d
Cleared
May 28, 1992
PROMEON HYDROGEL DRESSING #45 STERILE W/ MESH
NAE
Dressing, Wound, Hydrogel Without Drug And/or Biologic
183d
Cleared
May 28, 1992
PROMEON HYDROGEL DRESSING #45 STERILE W/O MESH
NAE
Dressing, Wound, Hydrogel Without Drug And/or Biologic
183d
Cleared
May 22, 1992
DISPOSABLE SKIN STAPLE REMOVER
MCZ
Suture Removal Kit
121d
Cleared
May 14, 1992
SIMON BREAST LESION LOCALIZATION NEEDLE
GDF
Guide, Needle, Surgical
192d
Cleared
May 13, 1992
SHARPLAN C02 ULTRASWIFT VAPORIZATION ENDPIECE
GEX
Powered Laser Surgical Instrument
40d
Cleared
May 11, 1992
SUOENA AFFINITY (TM) MODEL #802
KCZ
Prosthesis, Breast, External, Used With Adhesive
41d
Cleared
May 11, 1992
SUTURE REMOVAL KIT, STERILE, DISPOSABLE
MCZ
Suture Removal Kit
110d
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