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
13870 General & Plastic Surgery devices
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
Cleared
Apr 18, 2008
50W CERALAS D 1950NM DIODE LASER
GEX
Powered Laser Surgical Instrument
210d
Cleared
Apr 17, 2008
COOK ODYSSEY HOLMIUM LASER SYSTEM, MODEL 30W
GEX
Powered Laser Surgical Instrument
51d
Cleared
Apr 16, 2008
C-QUR EDGE MESH V-PATCH
FTL
Mesh, Surgical, Polymeric
36d
Cleared
Apr 16, 2008
C-QUR LITE MESH V-PATCH
FTL
Mesh, Surgical, Polymeric
36d
Cleared
Apr 16, 2008
PALOMAR ASPIRE LASER PLATFORM
GEX
Powered Laser Surgical Instrument
47d
Cleared
Apr 16, 2008
CONVENIENCE KIT FOR SINGLE-INCISION LAPAROSCOPIC SURGERY AND OTHER ADVANCED LAPAROSCOPIC PROCEDURES
KDD
Kit, Surgical Instrument, Disposable
198d
Cleared
Apr 10, 2008
CHROMOPHARE E-SERIES
FSY
Light, Surgical, Ceiling Mounted
14d
Cleared
Apr 10, 2008
COOLTOUCH MODELS LC215 AND COOLLIPO
GEX
Powered Laser Surgical Instrument
78d
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