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
13697 General & Plastic Surgery devices
Cleared
Jun 08, 2016
Sony IP Converter NU-IP40S
GCJ
Laparoscope, General & Plastic Surgery
48d
Cleared
Jun 08, 2016
Miromatrix Biological Mesh
OXH
Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery
117d
Cleared
Jun 03, 2016
Coated VICRYU (Polyglactin 91O)Sterile Synthetic Absorbable Suture Cartridges, ETHIBOND Polybutilate Coated Polyester Sterile Synthetic Non-Absorbable Suture Cartridges, PROXISURE Suturing Device
GAM
Suture, Absorbable, Synthetic, Polyglycolic Acid
169d
Cleared
Jun 03, 2016
LunulaLaser
PDZ
Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
214d
Cleared
Jun 02, 2016
O-pel Laser and families of probe delivery devices
GEX
Powered Laser Surgical Instrument
150d
Cleared
Jun 02, 2016
LENS Camera Control Unit-WiFi, LENS Camera Unit-Non-WiFi, LENS camera head, Camera Coupler, Tablet Application
GCJ
Laparoscope, General & Plastic Surgery
168d
Cleared
Jun 02, 2016
Helios III
GEX
Powered Laser Surgical Instrument
247d
Cleared
Jun 02, 2016
MTR550 (Tentative) Antimicrobial Silver Wound Gel
FRO
Dressing, Wound, Drug
273d
Cleared
Jun 02, 2016
ABC D-FLEX PROBE
GEI
Electrosurgical, Cutting & Coagulation & Accessories
392d
Cleared
Jun 01, 2016
Voyant Open Fusion Device
GEI
Electrosurgical, Cutting & Coagulation & Accessories
201d
Cleared
May 31, 2016
CapSure Fixation System - Straight 5mm x 37 cm – 30 Permanent fasteners, CapSure Fixation System - Straight 5mm x 37 cm – 15 Permanent fasteners
GDW
Staple, Implantable
60d
Cleared
May 31, 2016
FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture
GAP
Suture, Nonabsorbable, Silk
88d
Cleared
May 31, 2016
KARL STORZ Endoscopic ICG Imaging System
OWN
Confocal Optical Imaging
264d
Cleared
May 26, 2016
Radiance Ultra Series ZeroWire Embedded
GCJ
Laparoscope, General & Plastic Surgery
24d
Cleared
May 26, 2016
Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug
FTM
Mesh, Surgical
27d
Cleared
May 26, 2016
Noxilizer Surgical Ruler
FTY
Tape, Measuring, Rulers And Calipers
93d
Cleared
May 26, 2016
AdTec
GCJ
Laparoscope, General & Plastic Surgery
105d
Cleared
May 25, 2016
Prometheus ChitoGauze XR PRO
QSY
Hemostatic Wound Dressing Without Thrombin Or Other Biologics
162d
Cleared
May 23, 2016
ARTOURA Breast Tissue Expanders with Smooth Surface
LCJ
Tissue Expander And Accessories
27d
Cleared
May 23, 2016
Agem Ag Mesh Dressing with Silver
FRO
Dressing, Wound, Drug
262d
Cleared
May 23, 2016
PINPOINT Endoscopic Fluorescence Imaging System
GCJ
Laparoscope, General & Plastic Surgery
410d
Cleared
May 20, 2016
CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal Miniprobes
OWN
Confocal Optical Imaging
94d
Cleared
May 20, 2016
Sunfire 32 Tanning Bed
LEJ
Booth, Sun Tan
268d
Cleared
May 19, 2016
C2 CryoBalloon Focal Pear Catheter
GEH
Unit, Cryosurgical, Accessories
41d
Cleared
May 19, 2016
Valleylab REM Polyhesive Infant Patient Return Electrode
GEI
Electrosurgical, Cutting & Coagulation & Accessories
106d
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