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
7622 General & Plastic Surgery devices
Cleared
Apr 25, 2019
Ranfac Cartilage Biopsy Needle
KNW
Instrument, Biopsy
163d
Cleared
Apr 24, 2019
IntelliCartTM System
JCX
Apparatus, Suction, Ward Use, Portable, Ac-powered
28d
Cleared
Apr 24, 2019
V-Laser
GEX
Powered Laser Surgical Instrument
160d
Cleared
Apr 22, 2019
CryoLab
GEH
Unit, Cryosurgical, Accessories
60d
Cleared
Apr 19, 2019
SPY Portable Handheld Imaging (SPY-PHI) System
OWN
Confocal Optical Imaging
29d
Not Cleared
Apr 19, 2019
PREVENA 125 and PREVENA PLUS 125 Therapy Units
QFC
Negative Pressure Wound Therapy Device For Reduction Of Wound Complications
400d
Cleared
Apr 18, 2019
Disposable Standard Clamp
GCJ
Laparoscope, General & Plastic Surgery
22d
Cleared
Apr 18, 2019
CryoTouch
GEH
Unit, Cryosurgical, Accessories
113d
Cleared
Apr 16, 2019
Linear Cutter Staplers and Loading Units for Single Use, Circular Staplers for Single Use
GDW
Staple, Implantable
244d
Cleared
Apr 15, 2019
NDOHD High Definition Imaging System (NDOHD)
LLZ
System, Image Processing, Radiological
53d
Cleared
Apr 15, 2019
Diode Laser Treatment System
GEX
Powered Laser Surgical Instrument
178d
Cleared
Apr 15, 2019
Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer
NLM
Laparoscope, General & Plastic Surgery, Reprocessed
192d
Cleared
Apr 15, 2019
Reprocessed HARMONIC ACE+ 7 Shears with Advanced Hemostasis
NLQ
Single-use Reprocessed Ultrasonic Surgical Instruments
236d
Cleared
Apr 11, 2019
Sonopet iQ Ultrasonic Aspirator System
LFL
Instrument, Ultrasonic Surgical
86d
Cleared
Apr 11, 2019
Endoform Restella
FTM
Mesh, Surgical
125d
Cleared
Apr 08, 2019
Ergoline Sunrise 7200 Hybrid Technology
LEJ
Booth, Sun Tan
109d
Cleared
Apr 04, 2019
Erbe APCapplicators
GEI
Electrosurgical, Cutting & Coagulation & Accessories
113d
Cleared
Apr 01, 2019
CUSA Clarity Ultrasonic Surgical Aspirator System
LFL
Instrument, Ultrasonic Surgical
59d
Cleared
Mar 29, 2019
BTL-084
PBX
Massager, Vacuum, Radio Frequency Induced Heat
84d
Cleared
Mar 28, 2019
AirSeal
HIF
Insufflator, Laparoscopic
44d
Cleared
Mar 28, 2019
V.A.C. DERMATAC Drape
OMP
Negative Pressure Wound Therapy Powered Suction Pump
294d
Cleared
Mar 27, 2019
MiMo(TM) Negative Pressure Wound Therapy System
OMP
Negative Pressure Wound Therapy Powered Suction Pump
252d
Cleared
Mar 26, 2019
OTIS Optical Coherence Tomography SYstem
NQQ
System, Imaging, Optical Coherence Tomography (oct)
35d
Cleared
Mar 22, 2019
EnVisio Navigation Sytem
NEU
Marker, Radiographic, Implantable
105d
Cleared
Mar 22, 2019
ELMED Laparoscopic Instruments and Accessories
GCJ
Laparoscope, General & Plastic Surgery
324d
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