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
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
Cleared
Nov 13, 2020
NEUWAVE Microwave Ablation System and Accessories
NEY
System, Ablation, Microwave And Accessories
303d
Cleared
Nov 12, 2020
da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments, and Accessories
NAY
System, Surgical, Computer Controlled Instrument
69d
Cleared
Nov 10, 2020
SnapshotNIR
MUD
Oximeter, Tissue Saturation
117d
Cleared
Nov 06, 2020
Medical RF
GEI
Electrosurgical, Cutting & Coagulation & Accessories
410d
Cleared
Nov 05, 2020
SPY-PHI System with SPY-PHI Fluorescence Assessment Software
OWN
Confocal Optical Imaging
87d
Cleared
Nov 03, 2020
Palm NRG cellulite and muscle toning body device
PBX
Massager, Vacuum, Radio Frequency Induced Heat
473d
Cleared
Nov 02, 2020
IcePearl 2.1 CX 90° Needle, IcePearl 2.1 CX L 90° Needle, IcePearl 2.1 CX Needle, IceFORCE 2.1 CX 90° Needle, IceFORCE 2.1 CX L 90° Needle, IceFORCE 2.1 CX Needle
GEH
Unit, Cryosurgical, Accessories
28d
Cleared
Nov 02, 2020
Ellusa Generator, Ellusa Bayonet Tip, Ellusa RF-Cobb Tip, Ellusa SP-Pack and Tips, Ellusa Tip Set
GEI
Electrosurgical, Cutting & Coagulation & Accessories
59d
Cleared
Nov 02, 2020
Ellusa Bipolar Wands
GEI
Electrosurgical, Cutting & Coagulation & Accessories
59d
Cleared
Oct 30, 2020
Aesculap Caiman 5 Seal and Cut Technology System
GEI
Electrosurgical, Cutting & Coagulation & Accessories
30d
Cleared
Oct 30, 2020
PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System, PICO Fluid Management Pack
OMP
Negative Pressure Wound Therapy Powered Suction Pump
88d
Cleared
Oct 28, 2020
Tri-Staple 2.0 Reloads
GDW
Staple, Implantable
30d
Cleared
Oct 28, 2020
Ultimate Contour, Ultimate Contour Mini
PBX
Massager, Vacuum, Radio Frequency Induced Heat
147d
Cleared
Oct 28, 2020
NP1 Instrument, Creo Electrosurgical System
NEY
System, Ablation, Microwave And Accessories
300d
Cleared
Oct 23, 2020
SURGIPHOR Wound Irrigation System
FQH
Lavage, Jet
88d
Cleared
Oct 23, 2020
PocketDoc™ Micro Wound Therapy System
OMP
Negative Pressure Wound Therapy Powered Suction Pump
268d
Cleared
Oct 22, 2020
AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories
GEX
Powered Laser Surgical Instrument
58d
Cleared
Oct 21, 2020
ReNew XR Handpiece, ReNew XR Handpiece 34cm, ReNew XR Handpiece 42cm, ReNew XR Handpiece 25cm, Ratcheted ReNew XR Handpiece 34cm
GEI
Electrosurgical, Cutting & Coagulation & Accessories
105d
Cleared
Oct 21, 2020
InnovaMatrix
KGN
Wound Dressing With Animal-derived Material(s)
306d
Cleared
Oct 21, 2020
C4 Fiducial Marker
NEU
Marker, Radiographic, Implantable
387d
Looking for a specific general & plastic surgery device? Search by device name, K-number or manufacturer.
Search all General & Plastic Surgery 510(k) devices