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
13646 General & Plastic Surgery devices
Cleared
Jul 28, 2017
Photodynamic Therapy Device
GEX
Powered Laser Surgical Instrument
186d
Cleared
Jul 27, 2017
truFreeze System
GEH
Unit, Cryosurgical, Accessories
21d
Cleared
Jul 27, 2017
TIGR Matrix Surgical Mesh
OWT
Mesh, Surgical, Absorbable, Abdominal Hernia
272d
Cleared
Jul 26, 2017
Hydrocleanse Antimicrobial Skin and Wound Care Solution
FRO
Dressing, Wound, Drug
44d
Cleared
Jul 25, 2017
CoMatryx Collagen Wound Dressing 1 gram pouch, CoMatryx Collagen Wound Dressing 1 gram vial, CoMatryx Collagen Wound Dressing 10 gram bottle
KGN
Wound Dressing With Animal-derived Material(s)
50d
Cleared
Jul 25, 2017
Monteris Medical NeuroBlate System
GEX
Powered Laser Surgical Instrument
88d
Cleared
Jul 25, 2017
LightMed Dental Laser System
GEX
Powered Laser Surgical Instrument
197d
Cleared
Jul 25, 2017
PHMB Antimicrobial Foam Wound Dressing
FRO
Dressing, Wound, Drug
265d
Cleared
Jul 19, 2017
Disposable Standard Clamp
GCJ
Laparoscope, General & Plastic Surgery
162d
Cleared
Jul 19, 2017
XPress BCD Breast Compression Device
POY
Post Breast Biopsy Hemostatic Breast Compression Device
229d
Cleared
Jul 17, 2017
BD ChloraShield IV Dressing with CHG Antimicrobial
FRO
Dressing, Wound, Drug
157d
Cleared
Jul 14, 2017
truFreeze Rapid AV Spray Kit
GEH
Unit, Cryosurgical, Accessories
50d
Cleared
Jul 14, 2017
Alma LipoFlow System
MUU
System, Suction, Lipoplasty
78d
Cleared
Jul 14, 2017
sensiFirm
PBX
Massager, Vacuum, Radio Frequency Induced Heat
134d
Cleared
Jul 14, 2017
Single Use Circular Stapler, Single Use Hemorrhoidal Circular Stapler, Single Patient Use Linear Stapler and Reload, Single Patient Use Linear Cutter and Reload, Single Patient Use Endo Cutter and Reload, Single Patient Use Transverse Cutter and Reload
GDW
Staple, Implantable
289d
Cleared
Jul 12, 2017
NIRA Beauty Skin Laser
OHS
Light Based Over The Counter Wrinkle Reduction
245d
Cleared
Jul 11, 2017
3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing
SEL
Securement Wound Dressing For Reduction Of Infection
15d
Cleared
Jul 10, 2017
Biodesign Parastomal Hernia Repair Graft
FTM
Mesh, Surgical
263d
Cleared
Jul 07, 2017
Thunder, Thunder VT, Thunder HR
GEX
Powered Laser Surgical Instrument
28d
Cleared
Jul 07, 2017
ZELTIQ CoolSculpting System
OOK
Dermal Cooling Pack/vacuum/massager
88d
Cleared
Jul 06, 2017
Dermal Cooling System
GEH
Unit, Cryosurgical, Accessories
55d
Cleared
Jul 06, 2017
Philips BlueControl
ONE
Powered Light Based Non-laser Surgical Instrument
87d
Cleared
Jul 06, 2017
CO2 Laser Therapy Systems
ONG
Powered Laser Surgical Instrument With Microbeamfractional Output
314d
Cleared
Jul 06, 2017
HPO Exotic, LP1, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux
LEJ
Booth, Sun Tan
413d
Cleared
Jul 03, 2017
Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector
NLQ
Single-use Reprocessed Ultrasonic Surgical Instruments
94d
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