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
Jul 20, 2023
VenaCure EVLT NeverTouch Procedure Kits
GEX
Powered Laser Surgical Instrument
20d
Cleared
Jul 20, 2023
The InMode System with the Morpheus8 Applicators
GEI
Electrosurgical, Cutting & Coagulation & Accessories
30d
Cleared
Jul 17, 2023
FloNavi Open Field Fluorescence Imaging System
OWN
Confocal Optical Imaging
152d
Cleared
Jul 13, 2023
HydroMARK Plus Breast Biopsy Site Marker
NEU
Marker, Radiographic, Implantable
373d
Cleared
Jul 11, 2023
CUSA Clarity Ultrasonic Surgical Aspirator System
LFL
Instrument, Ultrasonic Surgical
144d
Cleared
Jul 07, 2023
Invia® Integrated Dressing
OMP
Negative Pressure Wound Therapy Powered Suction Pump
242d
Cleared
Jul 06, 2023
Laparoscope (21033FA, 21033FC, 21033WA, 21033WC, 20533FA, 20533FC, 20533WA, 20533WC)
GCJ
Laparoscope, General & Plastic Surgery
90d
Cleared
Jul 06, 2023
VYBE RF Electrosurgical System
GEI
Electrosurgical, Cutting & Coagulation & Accessories
92d
Cleared
Jul 05, 2023
Universal Seal (5-12 mm)
GCJ
Laparoscope, General & Plastic Surgery
56d
Cleared
Jul 03, 2023
LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001
OLP
Over-the-counter Powered Light Based Laser For Acne
109d
Cleared
Jun 29, 2023
OverStitch NXT Endoscopic Suturing System
OCW
Endoscopic Tissue Approximation Device
30d
Cleared
Jun 27, 2023
Unistik® 3 Single-Use Safety Lancets:- Extra (21G), Normal (23G), Comfort (28G), Gentle (30G)
FMK
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
68d
Cleared
Jun 26, 2023
ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113)
GEI
Electrosurgical, Cutting & Coagulation & Accessories
87d
Cleared
Jun 26, 2023
AB1 Electrosurgical Instrument, Creo Electrosurgical System
NEY
System, Ablation, Microwave And Accessories
265d
Cleared
Jun 23, 2023
KOH Ultramicro Injection Cannula (26167NN)
GCJ
Laparoscope, General & Plastic Surgery
133d
Cleared
Jun 21, 2023
da Vinci E-200 Electrosurgical Generator
GEI
Electrosurgical, Cutting & Coagulation & Accessories
54d
Cleared
Jun 21, 2023
Connected OR Hub with Device and Voice Control
GCJ
Laparoscope, General & Plastic Surgery
82d
Cleared
Jun 21, 2023
Antibacterial Bandage
FRO
Dressing, Wound, Drug
412d
Cleared
Jun 20, 2023
Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option)
IZI
System, X-ray, Angiographic
67d
Cleared
Jun 15, 2023
ERBEJET® 2 System
FQH
Lavage, Jet
65d
Cleared
Jun 12, 2023
Genadyne Hybrid Foam Dressings
OMP
Negative Pressure Wound Therapy Powered Suction Pump
348d
Cleared
Jun 09, 2023
NovoGen Wound Matrix
KGN
Wound Dressing With Animal-derived Material(s)
472d
Cleared
Jun 06, 2023
AviClear Laser System
GEX
Powered Laser Surgical Instrument
88d
Cleared
Jun 05, 2023
ArtiSential Laparoscopic Instruments-Electrodes
GEI
Electrosurgical, Cutting & Coagulation & Accessories
101d
Cleared
Jun 01, 2023
Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)
GEX
Powered Laser Surgical Instrument
56d
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