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
18368
Total
18322
Cleared
136d
Avg (2y)
1976
Since
18368 General & Plastic Surgery devices
Cleared
Dec 13, 2019
EPIFLO-28
KPJ
Chamber, Oxygen, Topical, Extremity
266d
Cleared
Dec 11, 2019
Exciplex
FTC
Light, Ultraviolet, Dermatological
231d
Cleared
Dec 10, 2019
Diode Laser 808nm
GEX
Powered Laser Surgical Instrument
88d
Cleared
Dec 06, 2019
Intense Pulsed Light Treatment System
ONF
Powered Light Based Non-laser Surgical Instrument With Thermal Effect
84d
Cleared
Dec 06, 2019
Dextile Anatomical Mesh
FTL
Mesh, Surgical, Polymeric
91d
Cleared
Dec 05, 2019
BTL-899
GEI
Electrosurgical, Cutting & Coagulation & Accessories
111d
Cleared
Dec 05, 2019
PICO 14 Single Use Negative Pressure Wound Therapy System
OMP
Negative Pressure Wound Therapy Powered Suction Pump
157d
Cleared
Dec 04, 2019
Epic 980
GEX
Powered Laser Surgical Instrument
90d
Cleared
Dec 04, 2019
MolecuLight i:X
QJF
Autofluorescence Imaging Adjunct Tool For Wounds
196d
Cleared
Dec 03, 2019
Promisemed Heel Blood Lancet
FMK
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
36d
Cleared
Dec 03, 2019
CO2 Laser Therapy System
GEX
Powered Laser Surgical Instrument
81d
Cleared
Dec 03, 2019
Deka Tiac 1
PBX
Massager, Vacuum, Radio Frequency Induced Heat
362d
Cleared
Dec 02, 2019
Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet
FMK
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
68d
Cleared
Dec 02, 2019
NasalCEASE and BleedCEASE
QSY
Hemostatic Wound Dressing Without Thrombin Or Other Biologics
341d
Cleared
Nov 27, 2019
Multi-modality workstation
ONF
Powered Light Based Non-laser Surgical Instrument With Thermal Effect
75d
Cleared
Nov 27, 2019
Orapeutic
OLR
Oral Wound Dressing
125d
Cleared
Nov 26, 2019
OrthoGold
PZL
Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers
126d
Cleared
Nov 25, 2019
VS3-IR
OWN
Confocal Optical Imaging
138d
Cleared
Nov 22, 2019
C2 CryoBalloon EndoGrip
OCX
Endoscopic Irrigation/suction System
22d
Cleared
Nov 22, 2019
Senhance Surgical System
NAY
System, Surgical, Computer Controlled Instrument
45d
Cleared
Nov 22, 2019
Hair Growth System
OAP
Laser, Comb, Hair
144d
Cleared
Nov 22, 2019
PREVENA PLUS Incision Management System (No Ag)
OMP
Negative Pressure Wound Therapy Powered Suction Pump
249d
Cleared
Nov 22, 2019
Applied Medical Laparoscopic Linear Cutter
GDW
Staple, Implantable
281d
Cleared
Nov 21, 2019
Canady Plasma SMART XL-1000 Electrosurgical Generator with Accessories
GEI
Electrosurgical, Cutting & Coagulation & Accessories
107d
Cleared
Nov 19, 2019
Dannik Laparoscopic Suction Irrigation System
GCJ
Laparoscope, General & Plastic Surgery
56d
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