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
13560 General & Plastic Surgery devices
Cleared
Dec 08, 2020
easy Hairfull
OAP
Laser, Comb, Hair
69d
Cleared
Dec 08, 2020
iHelmet Laser Comb
OAP
Laser, Comb, Hair
88d
Cleared
Dec 07, 2020
GIA Stapler with Tri-Staple Technology
GDW
Staple, Implantable
82d
Cleared
Dec 07, 2020
Vortex Radial Spray Catheter
GEH
Unit, Cryosurgical, Accessories
220d
Cleared
Dec 03, 2020
Tricoglam Home Use
OAP
Laser, Comb, Hair
402d
Cleared
Dec 01, 2020
SLIMUS
PKT
Laser For Disruption Of Adipocyte Cells For Aesthetic Use
405d
Cleared
Nov 30, 2020
Avenda Health Treatment System
GEX
Powered Laser Surgical Instrument
161d
Cleared
Nov 30, 2020
Smoke Evacuation Fingerswitch, Smoke evacuation system with electrosurgical pencil
GEI
Electrosurgical, Cutting & Coagulation & Accessories
290d
Cleared
Nov 25, 2020
Dermatological Carbon Dioxide Laser Systems
GEX
Powered Laser Surgical Instrument
107d
Cleared
Nov 24, 2020
RD QUICK LOAD SUTURE, 0 Polyester, RD QUICK LOAD SUTURE, 2-0 Polyester, RD QUCIK LOAD SUTURE, 2-0 Polypropylene
GAS
Suture, Nonabsorbable, Synthetic, Polyester
39d
Cleared
Nov 24, 2020
RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical Suture
GAS
Suture, Nonabsorbable, Synthetic, Polyester
42d
Cleared
Nov 24, 2020
C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge
GEH
Unit, Cryosurgical, Accessories
53d
Cleared
Nov 24, 2020
RF Surgical Generator
GEI
Electrosurgical, Cutting & Coagulation & Accessories
231d
Cleared
Nov 23, 2020
Mirus Ligating Clip, Mirus Ligating Clip Applier
FZP
Clip, Implantable
306d
Cleared
Nov 20, 2020
Smoke Evacuation Button Switch Pencil, Non-Ext., 10ft, D1, Smoke Evacuation Button Switch Pencil, Non-Ext., 15ft, D1, Smoke Evacuation Button Switch Pencil, Non-Ext., 10ft, D2, Smoke Evacuation Button Switch Pencil, Non-Ext., 15ft, D2, Telescopic Smoke Evacuation Button Switch Pencil, 10ft, Telescopic Smoke Evacuation Button Switch Pencil, 15ft, Telescopic Smoke Evacuation Button Switch Pencil, 15ft, Telescopic Smoke Evacuation Button Switch Pencil, Lock, 15ft
GEI
Electrosurgical, Cutting & Coagulation & Accessories
51d
Cleared
Nov 20, 2020
Silatrix Oral Gel
OLR
Oral Wound Dressing
123d
Cleared
Nov 19, 2020
Laser Therapy Device
GEX
Powered Laser Surgical Instrument
50d
Cleared
Nov 19, 2020
Carewear Firefly Wrinkle Reduction
OHS
Light Based Over The Counter Wrinkle Reduction
85d
Cleared
Nov 19, 2020
StarWalker
GEX
Powered Laser Surgical Instrument
108d
Cleared
Nov 19, 2020
K2 MOBILE
GEX
Powered Laser Surgical Instrument
248d
Cleared
Nov 18, 2020
Chrome
GEX
Powered Laser Surgical Instrument
79d
Cleared
Nov 18, 2020
Viveve System
GEI
Electrosurgical, Cutting & Coagulation & Accessories
266d
Cleared
Nov 17, 2020
Disposable Trocar
GCJ
Laparoscope, General & Plastic Surgery
49d
Cleared
Nov 16, 2020
Nd: YAG Laser Therapy Systems HM-YL900
GEX
Powered Laser Surgical Instrument
56d
Cleared
Nov 16, 2020
Sientra OPUS Silicone Gel Breast Implant Sizer
MRD
Mammary Sizer
243d
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