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
13853 General & Plastic Surgery devices
Cleared
May 05, 2008
AUTO SUTURE ENDO GIA STAPLERS WITH ENDO GIA SINGLE USE LOADING UNITS WITH STAPLE LINE REINFORCEMENT
GDW
Staple, Implantable
35d
Cleared
May 02, 2008
MOBLVAC W.C.
BTA
Pump, Portable, Aspiration (manual Or Powered)
7d
Cleared
May 02, 2008
AQUACEL HYDROFIBER WOUND DRESSING AND AG HYDROFIBER DRESSING
FRO
Dressing, Wound, Drug
80d
Cleared
May 02, 2008
LB MEDICAL INFLATABLE TISSUE ELEVATOR/EXPANDER SYSTEM
FZW
Expander, Surgical, Skin Graft
100d
Cleared
May 02, 2008
ZELTIQ AESTHETICS CLN1 DERMAL COOLING DEVICE
GEX
Powered Laser Surgical Instrument
106d
Cleared
May 01, 2008
SUPRASORB A +AG
FRO
Dressing, Wound, Drug
344d
Cleared
Apr 30, 2008
ORWELL FLUID COLLECTION AND DISPOSAL SYSTEM
JCX
Apparatus, Suction, Ward Use, Portable, Ac-powered
35d
Cleared
Apr 30, 2008
WG-SURGICAL SUTURES WITH NEEDLE
NEW
Suture, Surgical, Absorbable, Polydioxanone
126d
Cleared
Apr 30, 2008
DEMETECH ABSORBABLE SURGICAL SUTURE PLAIN & CHROMIC GUT
GAL
Suture, Absorbable, Natural
197d
Cleared
Apr 29, 2008
TRANSPOSAL ULTRA SYSTEMS
JCX
Apparatus, Suction, Ward Use, Portable, Ac-powered
15d
Cleared
Apr 25, 2008
IFS LASER SYSTEM
GEX
Powered Laser Surgical Instrument
143d
Cleared
Apr 25, 2008
PURACOL PLUS AG COLLAGEN MICROSCAFFOLD WOUND DRESSING
FRO
Dressing, Wound, Drug
324d
Cleared
Apr 24, 2008
SPARMAX ASPIRATOR, MODELS TC-2000V ND VC-701
JCX
Apparatus, Suction, Ward Use, Portable, Ac-powered
113d
Cleared
Apr 23, 2008
QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF POLYDIOXANONE (PDO)
NEW
Suture, Surgical, Absorbable, Polydioxanone
16d
Cleared
Apr 23, 2008
DOUBLE ARMED MENISCAL NEEDLES WITH SIZE #2-0 ORTHOCORD, MENISCAL NEEDLE WITH WIRE EYELET & 3 FREE STRANDS OF SIZE #2-0
NEW
Suture, Surgical, Absorbable, Polydioxanone
22d
Cleared
Apr 23, 2008
CENTURION SORBAVIEW OTC
NAD
Dressing, Wound, Occlusive
57d
Cleared
Apr 23, 2008
DERMA SCIENCES MEDIHONEY DRESSINGS WITH ACTIVE MANUKA HONEY
FRO
Dressing, Wound, Drug
77d
Cleared
Apr 23, 2008
SPECTRA VRMIII Q-SWITCHED ND: YAG LASER SYSTEM AND DYE HANDPIECES
GEX
Powered Laser Surgical Instrument
83d
Cleared
Apr 23, 2008
ELIPO
GEX
Powered Laser Surgical Instrument
114d
Cleared
Apr 23, 2008
ELTA ADVANCED WOUND WASH
FRO
Dressing, Wound, Drug
124d
Cleared
Apr 23, 2008
ANASEPT ANTIMICROBIAL SKIN AND WOUND CLEANSERS
FRO
Dressing, Wound, Drug
127d
Cleared
Apr 21, 2008
MODIFICATION TO ENDOFAST RELIANT SYSTEM
FTL
Mesh, Surgical, Polymeric
27d
Cleared
Apr 21, 2008
AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANT
KKY
Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
56d
Cleared
Apr 21, 2008
MARIONETTE SA, MODEL 001 001 & 001 002
GCJ
Laparoscope, General & Plastic Surgery
203d
Cleared
Apr 21, 2008
DIRECTVIEW, LIGHTGUIDE, MODEL(S) 10RLL-320 LAPAROSCOPE, 10DLG-320 DISPOSABLE LIGHT GUIDE FOR ABOVE
GCJ
Laparoscope, General & Plastic Surgery
217d
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