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
7617 General & Plastic Surgery devices
Cleared
Apr 02, 2020
ARC 400
GEI
Electrosurgical, Cutting & Coagulation & Accessories
101d
Cleared
Apr 02, 2020
Medone Ultra, Medextra
KNW
Instrument, Biopsy
241d
Cleared
Apr 02, 2020
MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration Needle, MED-L Bone Marrow Biopsy and Aspiration System, MED-B Bone Marrow Biopsy System, MED-J Bone Marrow Biopsy and Aspiration System
KNW
Instrument, Biopsy
241d
Cleared
Apr 01, 2020
Magnetic Surgical System
PNL
Magnetic Surgical System
275d
Cleared
Apr 01, 2020
Venus VivaTM
GEI
Electrosurgical, Cutting & Coagulation & Accessories
345d
Cleared
Mar 31, 2020
Trigger Switch and Cord
GEI
Electrosurgical, Cutting & Coagulation & Accessories
35d
Cleared
Mar 31, 2020
CytoCore
KNW
Instrument, Biopsy
56d
Cleared
Mar 31, 2020
da Vinci X and Xi Surgical System
NAY
System, Surgical, Computer Controlled Instrument
511d
Cleared
Mar 30, 2020
T-Line Hernia Mesh
FTL
Mesh, Surgical, Polymeric
138d
Cleared
Mar 30, 2020
Tevdek II, Silky II Polydek, 'Cottony' II, NextStitch
GAT
Suture, Nonabsorbable, Synthetic, Polyethylene
201d
Cleared
Mar 27, 2020
Silhouette Instalift
GAM
Suture, Absorbable, Synthetic, Polyglycolic Acid
66d
Cleared
Mar 27, 2020
SkyPulse
GEX
Powered Laser Surgical Instrument
88d
Cleared
Mar 27, 2020
HBP6 Settable, Resorbable Hemostatic Bone Paste
MTJ
Wax, Bone
147d
Cleared
Mar 27, 2020
TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large)
FTL
Mesh, Surgical, Polymeric
206d
Cleared
Mar 26, 2020
AbClose - Port Site Closure Device
OCW
Endoscopic Tissue Approximation Device
87d
Cleared
Mar 26, 2020
Ellipse Frax 1940 for Ellipse Nordlys and Ellipse Ydun
GEX
Powered Laser Surgical Instrument
157d
Cleared
Mar 26, 2020
TIGR Matrix Surgical Mesh, TIGR Surgical Mesh
OWT
Mesh, Surgical, Absorbable, Abdominal Hernia
269d
Cleared
Mar 25, 2020
TempSure System
PBX
Massager, Vacuum, Radio Frequency Induced Heat
54d
Cleared
Mar 25, 2020
Shapiro MD model laser 272
OAP
Laser, Comb, Hair
85d
Cleared
Mar 25, 2020
LightWalker Laser System Family
GEX
Powered Laser Surgical Instrument
86d
Cleared
Mar 25, 2020
Cry-Ac®, Cry-Ac-3®, Cry-Baby
GEH
Unit, Cryosurgical, Accessories
90d
Cleared
Mar 25, 2020
IPL + Diode Laser Machine
ONF
Powered Light Based Non-laser Surgical Instrument With Thermal Effect
114d
Cleared
Mar 25, 2020
STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device
NEW
Suture, Surgical, Absorbable, Polydioxanone
230d
Cleared
Mar 24, 2020
PlasmaBlade X 3.0S LIGHT
GEI
Electrosurgical, Cutting & Coagulation & Accessories
92d
Cleared
Mar 24, 2020
Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch
GEI
Electrosurgical, Cutting & Coagulation & Accessories
132d
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