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
18201
Total
18157
Cleared
138d
Avg (2y)
1976
Since
4091 General & Plastic Surgery devices
Cleared
Jun 20, 2019
EmBody System
PBX
Massager, Vacuum, Radio Frequency Induced Heat
190d
Cleared
Jun 19, 2019
STOP U (Packed Black USA), STOP U (Packed White USA)
PAY
Over-the-counter Radiofrequency Coagulation Device For Wrinkle Reduction
261d
Cleared
Jun 18, 2019
NanoKnife System
OAB
Low Energy Direct Current Thermal Ablation System
194d
Cleared
Jun 18, 2019
Bovine Pericardial Tissue Patch
FTM
Mesh, Surgical
280d
Cleared
Jun 17, 2019
Q-Switched Nd: YAG Laser System
GEX
Powered Laser Surgical Instrument
68d
Cleared
Jun 14, 2019
Silhouette Featherlift / Silhouette Lift
GAW
Suture, Nonabsorbable, Synthetic, Polypropylene
31d
Cleared
Jun 14, 2019
CLARITY II Laser System
GEX
Powered Laser Surgical Instrument
175d
Cleared
Jun 14, 2019
UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope
PEM
Dental Barriers And Sleeves
203d
Cleared
Jun 13, 2019
Electrosurgical Generator
GEI
Electrosurgical, Cutting & Coagulation & Accessories
175d
Cleared
Jun 12, 2019
Argon Handset
GEI
Electrosurgical, Cutting & Coagulation & Accessories
51d
Cleared
Jun 12, 2019
Viveve System 2.0
GEI
Electrosurgical, Cutting & Coagulation & Accessories
111d
Cleared
Jun 12, 2019
Phasix ST Mesh with Open Positioning System
OWT
Mesh, Surgical, Absorbable, Abdominal Hernia
131d
Cleared
Jun 12, 2019
J-Type Marrow Biopsy Needle,T-Type Marrow Biopsy Needle,Tweezer Bone Marrow Biopsy Needle,
KNW
Instrument, Biopsy
131d
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
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