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
18368
Total
18322
Cleared
136d
Avg (2y)
1976
Since
18368 General & Plastic Surgery devices
Cleared
Dec 02, 2022
Parietene Macroporous Mesh
FTL
Mesh, Surgical, Polymeric
46d
Cleared
Dec 02, 2022
Maestro Platform
FQO
Table, Operating-room, Ac-powered
200d
Cleared
Dec 02, 2022
SUREcore Plus Biopsy Instrument
KNW
Instrument, Biopsy
274d
Cleared
Dec 01, 2022
IPL Cooling Hair Removal Device
OHT
Light Based Over-the-counter Hair Removal
84d
Cleared
Nov 30, 2022
Lancing System, Sterile Lancet for Single Use, Lancing Device
QRL
Multiple Use Blood Lancet For Single Patient Use Only
106d
Cleared
Nov 30, 2022
EEA Circular Stapler with Tri-Staple Technology
GDW
Staple, Implantable
162d
Cleared
Nov 29, 2022
Signia™ Small Diameter Reloads Including Regular (Round) Tip Version
GDW
Staple, Implantable
89d
Cleared
Nov 29, 2022
Disposable Safety Lancet
FMK
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
111d
Cleared
Nov 29, 2022
SmartSurgN Visualization System
OWN
Confocal Optical Imaging
347d
Cleared
Nov 28, 2022
Facet Manatee Reusable Lancing Base
QRL
Multiple Use Blood Lancet For Single Patient Use Only
59d
Cleared
Nov 28, 2022
da Vinci E-200 Electrosurgical Generator
GEI
Electrosurgical, Cutting & Coagulation & Accessories
60d
Cleared
Nov 28, 2022
T-Line Hernia Mesh
FTL
Mesh, Surgical, Polymeric
181d
Cleared
Nov 23, 2022
TempSure System
GEI
Electrosurgical, Cutting & Coagulation & Accessories
28d
Cleared
Nov 23, 2022
LDE4 Lancing Device
QRL
Multiple Use Blood Lancet For Single Patient Use Only
82d
Cleared
Nov 23, 2022
Electrosurgical Pencil (OBS-Db, OBS-Dr, OBS-Dc, OBS-Df, OBS-Di, OBS-De)
GEI
Electrosurgical, Cutting & Coagulation & Accessories
154d
Cleared
Nov 22, 2022
da Vinci X Surgical System (IS4200), da Vinci Xi Surgical System (IS4000)
NAY
System, Surgical, Computer Controlled Instrument
53d
Cleared
Nov 22, 2022
Renasys Edge (66803126)
OMP
Negative Pressure Wound Therapy Powered Suction Pump
54d
Cleared
Nov 22, 2022
LED Light Therapy Mask (model: MK66R-B)
OHS
Light Based Over The Counter Wrinkle Reduction
140d
Cleared
Nov 22, 2022
Canady Flex RoboWrist
GCJ
Laparoscope, General & Plastic Surgery
449d
Cleared
Nov 21, 2022
Miro3D Wound Matrix
KGN
Wound Dressing With Animal-derived Material(s)
31d
Cleared
Nov 21, 2022
Disposable Sterile Lancet
QRL
Multiple Use Blood Lancet For Single Patient Use Only
118d
Cleared
Nov 21, 2022
SR-1 Skin Treatment System
ONG
Powered Laser Surgical Instrument With Microbeamfractional Output
203d
Cleared
Nov 18, 2022
MANTA Laser
GEX
Powered Laser Surgical Instrument
72d
Cleared
Nov 18, 2022
Facet Blood Lancets
QRL
Multiple Use Blood Lancet For Single Patient Use Only
88d
Cleared
Nov 18, 2022
Hair Growth Device
OAP
Laser, Comb, Hair
94d
Looking for a specific general & plastic surgery device? Search by device name, K-number or manufacturer.
Search all General & Plastic Surgery 510(k) devices