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
18256
Total
18211
Cleared
136d
Avg (2y)
1976
Since
7617 General & Plastic Surgery devices
Cleared
Jun 26, 2020
D-Stat Radial Topical Hemostat
QSX
Hemostatic Wound Dressing With Thrombin Or Other Biologics
99d
Cleared
Jun 24, 2020
Nd: YAG Laser Therapy Systems
GEX
Powered Laser Surgical Instrument
191d
Cleared
Jun 22, 2020
O-Mec 690 Series Laparoscopes
GCJ
Laparoscope, General & Plastic Surgery
54d
Cleared
Jun 22, 2020
Opera Lebody (Gold), Opera Lebody (Zafiro)
OHS
Light Based Over The Counter Wrinkle Reduction
59d
Cleared
Jun 19, 2020
Kogent Torus Ultrasonic Aspirator
LFL
Instrument, Ultrasonic Surgical
240d
Cleared
Jun 17, 2020
ArtiSential Laparoscopic Instruments - Electrodes
GEI
Electrosurgical, Cutting & Coagulation & Accessories
77d
Cleared
Jun 17, 2020
LT Antibacterial Alginate with Silver Dressing
FRO
Dressing, Wound, Drug
281d
Cleared
Jun 16, 2020
Foot Control Electrosurgical Pencil, Push Button Electrosurgical Pencil, Rocker Switch Electrosurgical Pencil, Holster, Electorde
GEI
Electrosurgical, Cutting & Coagulation & Accessories
274d
Cleared
Jun 15, 2020
CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Enevlope (extra extra large) (SubQ)
FTM
Mesh, Surgical
28d
Cleared
Jun 11, 2020
E>EyeC
ONF
Powered Light Based Non-laser Surgical Instrument With Thermal Effect
94d
Cleared
Jun 10, 2020
Hemospray Endoscopic Hemostat
QAU
Hemostatic Device For Endoscopic Gastrointestinal Use
58d
Cleared
Jun 09, 2020
DANNIK Disposable Monopolar Laparoscopic Instrument
GEI
Electrosurgical, Cutting & Coagulation & Accessories
49d
Cleared
Jun 09, 2020
Venus Epileve
GEX
Powered Laser Surgical Instrument
75d
Cleared
Jun 09, 2020
CO2 Laser System
GEX
Powered Laser Surgical Instrument
153d
Cleared
Jun 05, 2020
Voyant Open Fusion Device
GEI
Electrosurgical, Cutting & Coagulation & Accessories
31d
Cleared
Jun 05, 2020
Exofin Fusion Skin Closure System
OMD
Cutaneous Tissue Adhesive With Mesh
368d
Cleared
Jun 04, 2020
Oxylight
GEX
Powered Laser Surgical Instrument
139d
Cleared
Jun 03, 2020
Hair Growth System
OAP
Laser, Comb, Hair
57d
Cleared
May 29, 2020
Crownjun Nylon Suture
GAR
Suture, Nonabsorbable, Synthetic, Polyamide
268d
Cleared
May 28, 2020
PicoSecond Nd: YAG Laser System
GEX
Powered Laser Surgical Instrument
128d
Cleared
May 28, 2020
Frozen N
GEH
Unit, Cryosurgical, Accessories
149d
Cleared
May 28, 2020
REVOLVE ENVI 600 Advanced Adipose System
MUU
System, Suction, Lipoplasty
160d
Cleared
May 27, 2020
Medical Diode Laser Hair Removal System
GEX
Powered Laser Surgical Instrument
86d
Cleared
May 27, 2020
Megadyne Telescoping Smoke Evacuation Pencil - 10ft tubing, Megadyne Telescoping Smoke Evacuation Pencil - 15ft tubing, Megadyne Telescoping Smoke Evacuation Soft Tissue Dissector, Megadyne Telescoping Soft Tissue Dissector
GEI
Electrosurgical, Cutting & Coagulation & Accessories
114d
Cleared
May 27, 2020
Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse
OLR
Oral Wound Dressing
177d
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