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
136d
Avg (2y)
1976
Since
7638 General & Plastic Surgery devices
Cleared
May 18, 2012
PERMACOL SURGICAL IMPLANT
FTM
Mesh, Surgical
80d
Cleared
May 17, 2012
HARONIS ACE LAPAROSCOPIC 5MM DIAMETER SHEARS 36CM LENGTH +ADAPTIVE TISSUE TECHNOLOGY HARMONIC ACE 5MM DIAMETER SHEARS 23
LFL
Instrument, Ultrasonic Surgical
69d
Cleared
May 16, 2012
PICO SINGLE USE NEGATIVE PRESSURE WOUND THERAPY SYSTEM
OMP
Negative Pressure Wound Therapy Powered Suction Pump
296d
Cleared
May 13, 2012
SIDELAZE LASER BEAM DELIVERY ACCESSORY FOR CYNOSURE 1440NM WAVELENGTH LASERS
GEX
Powered Laser Surgical Instrument
30d
Cleared
May 10, 2012
AQUAMANTYS3 9.5 XL BIPOLAR SEALER
GEI
Electrosurgical, Cutting & Coagulation & Accessories
78d
Cleared
May 03, 2012
ENDO CLIP III 5MM CLIP APPLIER
FZP
Clip, Implantable
14d
Cleared
May 02, 2012
ACCUMESH DEPLOYMENT SYSTEM
ORQ
Mesh, Surgical, Deployer
16d
Cleared
Apr 30, 2012
SINGLE-SITE MEDIUM-LARGE CLIP APPLIER, SINGLE-SITE CADIERE GRASPER, SINGLE-SITE FUNDUS GRASPER, SINGLE-SITE CROCODILE
NAY
System, Surgical, Computer Controlled Instrument
97d
Cleared
Apr 26, 2012
C-QUR RPM MESH
FTL
Mesh, Surgical, Polymeric
17d
Cleared
Apr 18, 2012
ON CALL CHOSEN LANCING DEVICE
FMK
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
156d
Cleared
Apr 12, 2012
CURAD ANTIBACTERIAL BANDAGE
FRO
Dressing, Wound, Drug
129d
Cleared
Apr 06, 2012
SIDE EFFECT WITH HAND CONTROLS, HOOK ELECTRODE WITH HAND CONTROLS, 2.3 WEDGE ELECTRODE WITH HAND CONTROLS, S90 WITH HAND
GEI
Electrosurgical, Cutting & Coagulation & Accessories
85d
Cleared
Apr 06, 2012
ARTHREX BIO-SUTURE
GAT
Suture, Nonabsorbable, Synthetic, Polyethylene
186d
Cleared
Apr 05, 2012
BIATAIN SILICONE AG FOAM DRESSING - ADHESIVE: 3X3 INCHES, 4X4 INCHES, & 5X5 INCHES
FRO
Dressing, Wound, Drug
17d
Cleared
Mar 15, 2012
LEVEEN SUPERSLIM NEEDLE ELECTRODE
GEI
Electrosurgical, Cutting & Coagulation & Accessories
148d
Cleared
Feb 27, 2012
VAPR VUE GENERATOR, VAPR 3 ELECTROSURGICAL SYSTEM, VAPR II ELECTROSURGICAL SYSTEM COOLPLUSE 90 AND COOLPLUSE 90 WITH HAN
GEI
Electrosurgical, Cutting & Coagulation & Accessories
88d
Cleared
Feb 23, 2012
COLLAGEN RIBBON
FTM
Mesh, Surgical
51d
Cleared
Feb 09, 2012
INTEGRA WOUND MATRIX (THIN)
KGN
Wound Dressing With Animal-derived Material(s)
112d
Cleared
Feb 06, 2012
AESCULAP HISTOACRYL AND HISTOACRYL BLUE TOPICAL SKIN ADHESIVE
MPN
Tissue Adhesive For The Topical Approximation Of Skin
210d
Cleared
Jan 30, 2012
ANGIODYNAMICS, INC. VENACURE NEVERTOUCH DIRECT PROCEDURE KIT
GEX
Powered Laser Surgical Instrument
145d
Cleared
Jan 26, 2012
CYNOSURE CELLULAZE LASER
OYW
Laser, Cellulite Appearance
510d
Cleared
Jan 25, 2012
TORNIER COLLAGEN COATED BIOFIBER SCAFFOLD
FTL
Mesh, Surgical, Polymeric
258d
Cleared
Jan 20, 2012
SURGICAL TISSUE MANAGEMENT SYSTEM
GEI
Electrosurgical, Cutting & Coagulation & Accessories
266d
Cleared
Jan 11, 2012
REPROCESSED HARMONIC SCALPEL
NLQ
Single-use Reprocessed Ultrasonic Surgical Instruments
198d
Cleared
Jan 10, 2012
VOLUSON E6/E8/E8EXPERT/E10
IYE
Accelerator, Linear, Medical
20d
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