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
1334 General & Plastic Surgery devices
Cleared
Sep 22, 2022
ProGrip Self-Gripping Polypropylene Mesh
FTL
Mesh, Surgical, Polymeric
209d
Cleared
Sep 20, 2022
LUOFUCON Collagen Wound Dressing
KGN
Wound Dressing With Animal-derived Material(s)
309d
Cleared
Sep 16, 2022
ECHELON ENDOPATH Staple Line Reinforcement
OXC
Mesh, Surgical, Absorbable, Staple Line Reinforcement
130d
Cleared
Sep 16, 2022
OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device
GEI
Electrosurgical, Cutting & Coagulation & Accessories
157d
Cleared
Sep 14, 2022
Arthrex SoftStitch
GAT
Suture, Nonabsorbable, Synthetic, Polyethylene
62d
Cleared
Sep 09, 2022
Arthrex SutureTape
GAT
Suture, Nonabsorbable, Synthetic, Polyethylene
122d
Cleared
Sep 01, 2022
Erchonia GVL
NHN
Powered Light Based Laser Non-thermal Instrument With Non-heating Effect For Adjunctive Use In Pain Therapy
57d
Cleared
Sep 01, 2022
Ambient HipVac 50 Wand with Integrated Finger Switches, RF20000 COBLATION System, WEREWOLF COBLATION System, WEREWOLF+ COBLATION System
GEI
Electrosurgical, Cutting & Coagulation & Accessories
185d
Cleared
Aug 26, 2022
Beamer AVEO Electrosurgical Generator, Beamer AVEO Argon Module, Beamer AVEO Cart, Beamer AVEO Wired Foot Pedal, Beamer AVEO Argon Pressure Reducer
GEI
Electrosurgical, Cutting & Coagulation & Accessories
242d
Cleared
Aug 24, 2022
V-Laser
GEX
Powered Laser Surgical Instrument
100d
Cleared
Aug 22, 2022
CUSA Clarity Ultrasonic Surgical Aspirator System
LFL
Instrument, Ultrasonic Surgical
60d
Cleared
Aug 22, 2022
Arthrex FiberTape and TigerTape Cerclage Sutures
HTN
Washer, Bolt Nut
91d
Cleared
Aug 19, 2022
1688 4K Camera System with Advanced Imaging Modality
GCJ
Laparoscope, General & Plastic Surgery
32d
Cleared
Aug 18, 2022
truFreeze Console, PN CC301
GEH
Unit, Cryosurgical, Accessories
20d
Cleared
Aug 15, 2022
da Vinci X/Xi (IS4200/IS4000) 8mm Reusable Instruments
NAY
System, Surgical, Computer Controlled Instrument
230d
Cleared
Aug 11, 2022
InstaFill Graft Delivery System, SIGNIFY Bioactive
FMF
Syringe, Piston
57d
Cleared
Jul 28, 2022
Beamer AVEO FILTER INTEGRATED ARGON PROBE 1.8mm x 160 cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 1.8 mm X 320 cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 2.3 mm X 230 cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 2.3 mm x 320 cm, Beamer AVEO FILTER INTEGRATED ARGON SIDEFIRE PROBE 2.3 mm x 230 cm
GEI
Electrosurgical, Cutting & Coagulation & Accessories
23d
Cleared
Jul 26, 2022
Invia Ease Negative Pressure Wound Therapy (NPWT) System
OMP
Negative Pressure Wound Therapy Powered Suction Pump
208d
Cleared
Jul 19, 2022
Joule diVa System
GEX
Powered Laser Surgical Instrument
230d
Cleared
Jul 15, 2022
CUSA Clarity Ultrasonic Surgical Aspirator System
LFL
Instrument, Ultrasonic Surgical
28d
Cleared
Jul 13, 2022
truSculpt iD
GEI
Electrosurgical, Cutting & Coagulation & Accessories
58d
Cleared
Jun 29, 2022
780 nm L11 LED Light Source with AIM
OWN
Confocal Optical Imaging
26d
Cleared
Jun 27, 2022
VersaOne Optical Trocar with Fixation Balloon Cannula, VersaOne Universal Fixation Balloon Cannula
GCJ
Laparoscope, General & Plastic Surgery
202d
Cleared
Jun 22, 2022
Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D 3D Anatomical Mesh, Versatex Monofilament Mesh
FTL
Mesh, Surgical, Polymeric
113d
Cleared
Jun 21, 2022
Lumenis Y&R Laser System
GEX
Powered Laser Surgical Instrument
361d
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