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
14003 General & Plastic Surgery devices
Cleared
May 19, 2003
MEGA 2000 SOFT DUAL CORD PATIENT RETURN ELECTRODE PAD
GEI
Electrosurgical, Cutting & Coagulation & Accessories
26d
Cleared
May 15, 2003
COLLAGEN TOPICAL WOUND DRESSING
KGN
Wound Dressing With Animal-derived Material(s)
52d
Cleared
May 15, 2003
PROXIMATE HCS HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES, MODEL PPH01
GDW
Staple, Implantable
52d
Cleared
May 15, 2003
BARD PELVISOFT ACELLULAR COLLAGEN BIOMESH
FTM
Mesh, Surgical
17d
Cleared
May 14, 2003
GUIDANT VASOVIEW ENDOSCOPIC VESSEL HARVESTING SYSTEM
GCJ
Laparoscope, General & Plastic Surgery
84d
Cleared
May 12, 2003
COOLTOUCH ND: YAG LASER SYSTEM
GEX
Powered Laser Surgical Instrument
90d
Cleared
May 09, 2003
SMARTXIDE
GEX
Powered Laser Surgical Instrument
22d
Cleared
May 06, 2003
ARAMIS II DERMATOLOGICAL LASER
GEX
Powered Laser Surgical Instrument
180d
Cleared
May 06, 2003
MONO-SWIFT
NEW
Suture, Surgical, Absorbable, Polydioxanone
55d
Cleared
Apr 21, 2003
SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL
FTM
Mesh, Surgical
41d
Cleared
Apr 16, 2003
ARTHROCARE PERCD SPINEWAND
GEI
Electrosurgical, Cutting & Coagulation & Accessories
20d
Cleared
Apr 15, 2003
LUMENIS FAMILY OF ULTRAPULSE SURGITOUCH CO2 SURGICAL LASERS
GEX
Powered Laser Surgical Instrument
90d
Cleared
Apr 14, 2003
POLRIS LV
GEX
Powered Laser Surgical Instrument
83d
Cleared
Apr 14, 2003
SKINTACT COOL CONTACT ELECTROSURGICAL GROUNDING PLATES
GEI
Electrosurgical, Cutting & Coagulation & Accessories
70d
Cleared
Apr 04, 2003
RADIONICS SINGLE USE GROUND PAD (DGP-HP)
GEI
Electrosurgical, Cutting & Coagulation & Accessories
29d
Cleared
Mar 31, 2003
CANDELA GENTLE LASE FAMILY OF LASER SYSTEM
GEX
Powered Laser Surgical Instrument
90d
Cleared
Mar 31, 2003
SURGASSIST STRAIGHT LINEAR STAPLER AND STRAIGHT LINEAR 4 ROW NO KNIFE DIGITAL LOADING UNITS WITH RELOADS
GDW
Staple, Implantable
28d
Cleared
Mar 31, 2003
QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLE
LRO
General Surgery Tray
24d
Cleared
Mar 28, 2003
ENDOSCOPIC LASER DELIVERY SYSTEM-LASERTX
GEX
Powered Laser Surgical Instrument
179d
Cleared
Mar 28, 2003
STAINLESS STEEL SURGICAL SUTURE, NON-ABSORBABLE
GAQ
Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
53d
Cleared
Mar 21, 2003
CHROMOPHARE X 65
FSY
Light, Surgical, Ceiling Mounted
95d
Cleared
Mar 21, 2003
CANDELA GENTLELASE FAMILY OF LASER SYSTEMS
GEX
Powered Laser Surgical Instrument
88d
Cleared
Mar 20, 2003
HISTOFREEZER WART REMOVAL SYSTEM OR OTHER PROPRIETARY NAME
GEH
Unit, Cryosurgical, Accessories
154d
Cleared
Mar 20, 2003
PROXIMATE PPH HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES, MODEL PPH03
GDW
Staple, Implantable
41d
Cleared
Mar 17, 2003
NEOSPORIN SCAR SOLUTION
MDA
Elastomer, Silicone, For Scar Management
90d
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