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
1323 General & Plastic Surgery devices
Cleared
Sep 26, 2023
DEKA PHYSIQ 360
PKT
Laser For Disruption Of Adipocyte Cells For Aesthetic Use
85d
Cleared
Sep 25, 2023
PEACH 2, PEACH 2 Duo, PEACH 2 go
OHT
Light Based Over-the-counter Hair Removal
84d
Cleared
Sep 22, 2023
MicroMatrix® Flex
KGN
Wound Dressing With Animal-derived Material(s)
170d
Cleared
Sep 21, 2023
BTL-899F
GEI
Electrosurgical, Cutting & Coagulation & Accessories
212d
Cleared
Sep 20, 2023
1788 4K Camera System with Advanced Imaging Modality
OWN
Confocal Optical Imaging
89d
Cleared
Sep 15, 2023
PENTO Nd:YAG and Alexandrite laser system
GEX
Powered Laser Surgical Instrument
87d
Cleared
Sep 14, 2023
Anovo Pedestal
QNM
Mountable Electromechanical Surgical System For Transluminal Approaches
57d
Cleared
Sep 11, 2023
Planar LED mate
OHT
Light Based Over-the-counter Hair Removal
213d
Cleared
Sep 08, 2023
MaxTack™ Motorized Fixation Device
OCW
Endoscopic Tissue Approximation Device
133d
Cleared
Aug 30, 2023
MONTAGE Settable, Resorbable Hemostatic Bone Putty
MTJ
Wax, Bone
679d
Cleared
Aug 29, 2023
LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420)
FZP
Clip, Implantable
27d
Cleared
Aug 28, 2023
SofWave System
OHV
Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
90d
Cleared
Aug 25, 2023
Lavieen
GEX
Powered Laser Surgical Instrument
255d
Cleared
Aug 18, 2023
Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control
GCJ
Laparoscope, General & Plastic Surgery
29d
Cleared
Aug 18, 2023
Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories: Foot switches (WA91311W, WA91321W)
GEI
Electrosurgical, Cutting & Coagulation & Accessories
63d
Cleared
Aug 18, 2023
ALLEVYN Ag+ Border Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Border Sacrum Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Surgical Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing
FRO
Dressing, Wound, Drug
268d
Cleared
Aug 16, 2023
EEA™Circular Stapler with Tri-Staple™ Technology and OrVil™ Transoral Circular Stapler Anvil
GAG
Stapler, Surgical
30d
Cleared
Aug 16, 2023
TA™ Stapler and Loading Unit with DST Series™ Technology
GAG
Stapler, Surgical
85d
Cleared
Aug 14, 2023
V-Laser
GEX
Powered Laser Surgical Instrument
123d
Cleared
Aug 14, 2023
Density
GEI
Electrosurgical, Cutting & Coagulation & Accessories
157d
Cleared
Aug 11, 2023
NuEra Tight RF Family
GEI
Electrosurgical, Cutting & Coagulation & Accessories
231d
Cleared
Aug 04, 2023
Bladeless Trocar – Artemis Lap Cannula
GCJ
Laparoscope, General & Plastic Surgery
81d
Cleared
Aug 04, 2023
Surgeon Controlled Arm
PNL
Magnetic Surgical System
240d
Cleared
Jul 31, 2023
Nooance Led And Laser Helmet
OAP
Laser, Comb, Hair
84d
Cleared
Jul 21, 2023
Erchonia Violet ZERONA® Z6 OTC
OLI
Fat Reducing Low Level Laser
60d
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