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
18288
Total
18243
Cleared
138d
Avg (2y)
1976
Since
13605 General & Plastic Surgery devices
Cleared
Jun 12, 2019
Eon FR
PKT
Laser For Disruption Of Adipocyte Cells For Aesthetic Use
470d
Cleared
Jun 11, 2019
Force Fiber Suture
GAT
Suture, Nonabsorbable, Synthetic, Polyethylene
29d
Cleared
Jun 06, 2019
da Vinci Handheld Camera
GCJ
Laparoscope, General & Plastic Surgery
48d
Cleared
Jun 05, 2019
HydroCision TenJet Device
HRX
Arthroscope
68d
Cleared
Jun 05, 2019
WalterLorenz Surgical Assist Arm Scope Holder
OCV
Endoscope Holder
91d
Cleared
Jun 04, 2019
PDS Barbed Suture, PDO MAXX Threads
NEW
Suture, Surgical, Absorbable, Polydioxanone
118d
Cleared
May 31, 2019
E240AG LCD Monitor, E240A LCD Monitor, JUSHA-E240AG LCD Monitor, JUJSHA-E240A LCD Monitor, C230A LCD Monitor, JUSHA-C230A LCD Monitor, C230M LCD Monitor, JUSHA-C230M LCD Monitor
GCJ
Laparoscope, General & Plastic Surgery
60d
Cleared
May 31, 2019
C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge
GEH
Unit, Cryosurgical, Accessories
116d
Cleared
May 31, 2019
Apis
FRO
Dressing, Wound, Drug
245d
Cleared
May 30, 2019
neXus Ultrasonic Surgical Aspirator System
LFL
Instrument, Ultrasonic Surgical
120d
Cleared
May 29, 2019
Silver High Performance Dressing
FRO
Dressing, Wound, Drug
154d
Cleared
May 24, 2019
Soliton Acoustic Wave Device
GEX
Powered Laser Surgical Instrument
81d
Cleared
May 23, 2019
Longterm NPWT Foam Dressing Kit
OMP
Negative Pressure Wound Therapy Powered Suction Pump
255d
Cleared
May 22, 2019
Erbe ESU Model VIO 3 with Accessories
GEI
Electrosurgical, Cutting & Coagulation & Accessories
51d
Cleared
May 22, 2019
Soniquence RF Generator and Soniquence Electrodes
GEI
Electrosurgical, Cutting & Coagulation & Accessories
147d
Cleared
May 21, 2019
Smith & Nephew Tablet Application
QGY
Mobile / Tablet Software Application To Control Settings Of Surgical And Endoscopic Camera
95d
Cleared
May 17, 2019
iRestore Professional 282
OAP
Laser, Comb, Hair
158d
Cleared
May 15, 2019
REMY Medical Therapy Laser System
PDZ
Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
128d
Cleared
May 10, 2019
L10 LED Light Source with AIM, L11 LED Light Source with AIM
OWN
Confocal Optical Imaging
21d
Cleared
May 10, 2019
Ergoline Inspiration 550 Hybrid Technology / Sound, Ergoline Inspiration 550 Hybrid Technology / AC / Sound, Ergoline Planet Fitness 42/4 Hybrid Light Technology / Sound
LEJ
Booth, Sun Tan
98d
Cleared
May 10, 2019
SteriStay
ORC
Air Filter Portable Apparatus
123d
Cleared
May 08, 2019
Electrosurgical accessory
GEI
Electrosurgical, Cutting & Coagulation & Accessories
176d
Cleared
May 06, 2019
Medline Electrocautery Pencil
GEI
Electrosurgical, Cutting & Coagulation & Accessories
54d
Cleared
May 03, 2019
AuraGen 123 Suction Lipoplasty System (A123)
MUU
System, Suction, Lipoplasty
84d
Cleared
May 02, 2019
SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface
MUD
Oximeter, Tissue Saturation
58d
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