FDA 510(k) General & Plastic Surgery Devices
About General & Plastic Surgery Devices
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
18146
Total
18103
Cleared
114d
Avg days
1976
Since
1323 General & Plastic Surgery devices
Cleared
Nov 22, 2023
IceSeed 1.5 CX 90º Needle (H7493967433170)
GEH
Unit, Cryosurgical, Accessories
84d
Cleared
Nov 21, 2023
KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit
OWN
Confocal Optical Imaging
53d
Cleared
Nov 17, 2023
Celox Rapid X-Ray Gauze
QSY
Hemostatic Wound Dressing Without Thrombin Or Other Biologics
260d
Cleared
Nov 16, 2023
NEUWAVE™ Microwave Ablation System and Accessories
NEY
System, Ablation, Microwave And Accessories
155d
Cleared
Nov 13, 2023
Accu-Chek Safe-T-Pro Uno Lancing Device
FMK
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
87d
Cleared
Nov 13, 2023
Accu-Chek Safe-T-Pro Plus Lancing Device
FMK
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
88d
Cleared
Nov 10, 2023
Skin and Wound Cleanser
FRO
Dressing, Wound, Drug
163d
Cleared
Nov 08, 2023
da Vinci SP Surgical System
NAY
System, Surgical, Computer Controlled Instrument
141d
Cleared
Nov 06, 2023
KARL STORZ ICG Imaging System
OWN
Confocal Optical Imaging
52d
Cleared
Nov 01, 2023
Inzii Ripstop Redeployable Retrieval System
GCJ
Laparoscope, General & Plastic Surgery
44d
Cleared
Oct 30, 2023
NuEra Tight RF Model OptiStream
PBX
Massager, Vacuum, Radio Frequency Induced Heat
227d
Cleared
Oct 27, 2023
EnCor Enspire™Breast Biopsy System (E4115, E4230)
KNW
Instrument, Biopsy
29d
Cleared
Oct 27, 2023
DEKA AGAIN PRO family
GEX
Powered Laser Surgical Instrument
31d
Cleared
Oct 27, 2023
GIA™ Stapler with Tri-Staple™ Technology
GAG
Stapler, Surgical
119d
Cleared
Oct 26, 2023
Antimicrobial Gelling Fiber Dressing with PHMB
FRO
Dressing, Wound, Drug
728d
Cleared
Oct 25, 2023
POWERSEAL Sealer and Divider
GEI
Electrosurgical, Cutting & Coagulation & Accessories
170d
Cleared
Oct 25, 2023
VVR Generator system
GEI
Electrosurgical, Cutting & Coagulation & Accessories
392d
Cleared
Oct 24, 2023
PlaDuo System
GEI
Electrosurgical, Cutting & Coagulation & Accessories
90d
Cleared
Oct 23, 2023
CleanSeal Advanced Bipolar Vessel Sealer Maryland
GEI
Electrosurgical, Cutting & Coagulation & Accessories
132d
Cleared
Oct 20, 2023
Echo
GEX
Powered Laser Surgical Instrument
85d
Cleared
Oct 17, 2023
Legend X Platform
GEI
Electrosurgical, Cutting & Coagulation & Accessories
29d
Cleared
Oct 13, 2023
The Evolve System with the Transform Applicator
GEI
Electrosurgical, Cutting & Coagulation & Accessories
143d
Cleared
Oct 12, 2023
Collagen Wound Dressing
KGN
Wound Dressing With Animal-derived Material(s)
171d
Cleared
Oct 03, 2023
KARL STORZ OR1™ SCB CONTROL (WU300)
ODA
Endoscopic Central Control Unit
54d
Cleared
Sep 29, 2023
Guardenia (GAR-1)
GCJ
Laparoscope, General & Plastic Surgery
24d
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