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
1338 General & Plastic Surgery devices
Cleared
Apr 13, 2022
MCL 31 Dermablate System
GEX
Powered Laser Surgical Instrument
406d
Cleared
Apr 08, 2022
ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler
GAG
Stapler, Surgical
142d
Cleared
Apr 08, 2022
SCOUT BX Delivery System
NEU
Marker, Radiographic, Implantable
210d
Cleared
Mar 24, 2022
Erchonia Zerona Z-Bed
OLI
Fat Reducing Low Level Laser
29d
Cleared
Mar 24, 2022
AviClear Laser System
GEX
Powered Laser Surgical Instrument
148d
Cleared
Mar 23, 2022
BD Surgiphor Antimicrobial Irrigation System
FQH
Lavage, Jet
128d
Cleared
Mar 23, 2022
LUOFUCON Extra Silver Gelling Fiber Dressing, LUOFUCON Silver Antibacterial Gelling Fiber Dressing
FRO
Dressing, Wound, Drug
378d
Cleared
Mar 16, 2022
Fiber Dust PRO
GEX
Powered Laser Surgical Instrument
30d
Cleared
Mar 11, 2022
Demetra Dermatoscope BDEM-01
PSN
Light Based Imaging
84d
Cleared
Mar 11, 2022
Unify Multifunction Energy Platform, CleanSeal Vessel Sealers, Unify Bipolar Resection Cables, Unify Wireless FootSwitch, Unify Cart
GEI
Electrosurgical, Cutting & Coagulation & Accessories
150d
Cleared
Mar 09, 2022
4K UHD LCD Monitor OEV321UH
GCJ
Laparoscope, General & Plastic Surgery
58d
Cleared
Mar 07, 2022
BTL-785W
GEI
Electrosurgical, Cutting & Coagulation & Accessories
284d
Cleared
Feb 25, 2022
Cool-tip RF Ablation System E Series
GEI
Electrosurgical, Cutting & Coagulation & Accessories
491d
Cleared
Feb 22, 2022
PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture
NEW
Suture, Surgical, Absorbable, Polydioxanone
204d
Cleared
Feb 17, 2022
da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System
NAY
System, Surgical, Computer Controlled Instrument
85d
Cleared
Feb 09, 2022
SDC4K Information Management System with Device and Voice Control Package
GCJ
Laparoscope, General & Plastic Surgery
27d
Cleared
Feb 04, 2022
HOLLYWOOD SPECTRA Laser System
GEX
Powered Laser Surgical Instrument
87d
Cleared
Feb 03, 2022
Sonopet iQ Ultrasonic Aspirator System
LFL
Instrument, Ultrasonic Surgical
57d
Cleared
Feb 02, 2022
Rosso
GEX
Powered Laser Surgical Instrument
285d
Cleared
Jan 31, 2022
8mm Monopolar Curved Scissors
NAY
System, Surgical, Computer Controlled Instrument
26d
Cleared
Jan 26, 2022
SmoothSkin Pure Mini
OHT
Light Based Over-the-counter Hair Removal
64d
Cleared
Jan 21, 2022
ETHICON Megadyne Electrosurgical Generator
GEI
Electrosurgical, Cutting & Coagulation & Accessories
59d
Cleared
Jan 14, 2022
Medline Universal Grounding Pad
GEI
Electrosurgical, Cutting & Coagulation & Accessories
192d
Cleared
Jan 14, 2022
Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film Dressing
OMP
Negative Pressure Wound Therapy Powered Suction Pump
479d
Cleared
Jan 07, 2022
Picocaremajesty
GEX
Powered Laser Surgical Instrument
184d
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