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
13830 General & Plastic Surgery devices
Cleared
Aug 19, 2011
SONAFINE WOUND DRESSING
FRO
Dressing, Wound, Drug
211d
Cleared
Aug 16, 2011
HAIRMAX DUAL 12
OAP
Laser, Comb, Hair
57d
Cleared
Aug 11, 2011
PAIRETEX OPTIMIZED COMPOSITE MESH (PCO-FX REFRENCES)
FTL
Mesh, Surgical, Polymeric
156d
Cleared
Aug 10, 2011
C7 XR IMAGING SYSTEM
NQQ
System, Imaging, Optical Coherence Tomography (oct)
103d
Cleared
Aug 09, 2011
COLLACARE DENTAL
KGN
Wound Dressing With Animal-derived Material(s)
180d
Cleared
Aug 08, 2011
ANTLIA III WOUND TREATMENT SYSTEM
OMP
Negative Pressure Wound Therapy Powered Suction Pump
88d
Cleared
Aug 08, 2011
CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES
OWN
Confocal Optical Imaging
115d
Cleared
Aug 03, 2011
ATRICURE CRYO MODULE SYSTEM
GEH
Unit, Cryosurgical, Accessories
14d
Cleared
Aug 03, 2011
VALUTRUS REUSABLE CIRCULAR STAPLER AND DISPOSABLE RELOADS
GDW
Staple, Implantable
97d
Cleared
Aug 03, 2011
TANDA MAX OTC SYSTEM
OHS
Light Based Over The Counter Wrinkle Reduction
140d
Cleared
Jul 28, 2011
SNAP (R) WOUND CARE SYSTEM
OKO
Negative Pressure Wound Therapy Non-powered Suction Apparatus
71d
Cleared
Jul 27, 2011
MEDIHONEY HYDROGEL SHEET DRESSINGS WITH ACTIVE LEPTOSPERMUM HONEY
FRO
Dressing, Wound, Drug
152d
Cleared
Jul 25, 2011
VISION ONE LASER SYSTEM
GEX
Powered Laser Surgical Instrument
84d
Cleared
Jul 22, 2011
MP 719
MTJ
Wax, Bone
50d
Cleared
Jul 22, 2011
SLIM E30 II CO2 LASER
ONG
Powered Laser Surgical Instrument With Microbeamfractional Output
106d
Cleared
Jul 21, 2011
V.A.C. 125 NEGATIVE PRESSURE WOUND THERAPY UNIT
OMP
Negative Pressure Wound Therapy Powered Suction Pump
76d
Cleared
Jul 21, 2011
CI-SNAP WOUND CARE SYSTEM
OKO
Negative Pressure Wound Therapy Non-powered Suction Apparatus
101d
Cleared
Jul 18, 2011
CANDELA GENTLELASE FAMILY OF LASERS
GEX
Powered Laser Surgical Instrument
87d
Cleared
Jul 18, 2011
DOMAIN SURGICAL SYSTEM
GEI
Electrosurgical, Cutting & Coagulation & Accessories
153d
Cleared
Jul 18, 2011
REPROCESSED ELECTROSURGICAL INSTRUMENT
NUJ
Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
175d
Cleared
Jul 14, 2011
STRYKER (R) PATIENT SPECIFIC POLYMER IMPLANT
GWO
Plate, Cranioplasty, Preformed, Alterable
87d
Cleared
Jul 11, 2011
ARAGON SURGICAL RF SYSTEM - 5MM LAPAROSCOPIC INSTRUMENT
GEI
Electrosurgical, Cutting & Coagulation & Accessories
110d
Cleared
Jul 08, 2011
MEDIOSTAR NEXT
GEX
Powered Laser Surgical Instrument
9d
Cleared
Jul 01, 2011
CORTEX CO2 / ER:YAG LASER SYSTEM
GEX
Powered Laser Surgical Instrument
93d
Cleared
Jul 01, 2011
SP DYNAMIS, SP SPECTRO, XS DYNAMIS, XS SPECTRO, XP DYNAMIS, XP SPECTRO, MODELS M021-4AF/3, M002-2A
GEX
Powered Laser Surgical Instrument
417d
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