FDA 510(k) General & Plastic Surgery Devices
About General & Plastic Surgery Devices
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
18146
Total
18103
Cleared
114d
Avg days
1976
Since
1318 General & Plastic Surgery devices
Cleared
Aug 09, 2024
MEDIDIODE
GEX
Powered Laser Surgical Instrument
406d
Cleared
Aug 08, 2024
SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499)
QZB
Software Controlled Endoscope And Instrument Holder
314d
Cleared
Aug 07, 2024
Stellar Imaging System
GCJ
Laparoscope, General & Plastic Surgery
69d
Cleared
Aug 07, 2024
Liposaver
QPB
System, Suction, Lipoplasty For Removal
1056d
Cleared
Aug 05, 2024
da Vinci E-200 Electrosurgical Generator
GEI
Electrosurgical, Cutting & Coagulation & Accessories
60d
Cleared
Aug 05, 2024
Universal Seal (5-12 mm)
GCJ
Laparoscope, General & Plastic Surgery
83d
Cleared
Aug 05, 2024
HybridTherm System
GEI
Electrosurgical, Cutting & Coagulation & Accessories
122d
Cleared
Aug 05, 2024
CellFX Percutaneous Electrode System (SYS3000)
GEI
Electrosurgical, Cutting & Coagulation & Accessories
137d
Cleared
Aug 02, 2024
MENTOR™ CPX™4 PLUS Enhance Breast Tissue Expander
LCJ
Tissue Expander And Accessories
32d
Cleared
Aug 02, 2024
Diode Laser Hair Removal System (MBT-Diode Laser)
GEX
Powered Laser Surgical Instrument
56d
Cleared
Aug 02, 2024
Da Vinci Monopolar and Bipolar Adapters (378896)
GEI
Electrosurgical, Cutting & Coagulation & Accessories
58d
Cleared
Aug 01, 2024
TLAB® Transvenous Liver Biopsy System (TF-18C)
DYB
Introducer, Catheter
98d
Cleared
Jul 31, 2024
Silverlon® Wound Contact, Burn Contact Dressing
FRO
Dressing, Wound, Drug
90d
Cleared
Jul 26, 2024
InnovaMatrix®FD
KGN
Wound Dressing With Animal-derived Material(s)
29d
Cleared
Jul 26, 2024
NEXA™ NPWT System
OMP
Negative Pressure Wound Therapy Powered Suction Pump
58d
Cleared
Jul 26, 2024
Resolv Endoscopic Hemostat System
QAU
Hemostatic Device For Endoscopic Gastrointestinal Use
211d
Cleared
Jul 25, 2024
Arthrex Synergy Vision Endoscopic Imaging System
GCJ
Laparoscope, General & Plastic Surgery
72d
Cleared
Jul 25, 2024
PMD Clean Redvolution (4005-moab-NA, 4005-moab-INT, 4005-pepper-NA, 4005-pepper-INT, 4005-cream-NA, 4005-cream-INT, 4005-twilight-NA , 4005-twilight-INT, 4005-grey-NA, 4005-grey- INT)
OHS
Light Based Over The Counter Wrinkle Reduction
86d
Cleared
Jul 24, 2024
P-SCOPE
GCJ
Laparoscope, General & Plastic Surgery
57d
Cleared
Jul 24, 2024
MISTI Silicone Implant
MIB
Elastomer, Silicone Block
90d
Cleared
Jul 24, 2024
InMode RF System
GEI
Electrosurgical, Cutting & Coagulation & Accessories
125d
Cleared
Jul 24, 2024
C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)
GEH
Unit, Cryosurgical, Accessories
159d
Cleared
Jul 22, 2024
Onycho Laser V
PDZ
Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
90d
Cleared
Jul 19, 2024
coactiv+™ Antimicrobial Wound Gel
FRO
Dressing, Wound, Drug
28d
Cleared
Jul 19, 2024
IntelliBlate Microwave Ablation System Console (IB-CON)
NEY
System, Ablation, Microwave And Accessories
150d
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