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
1320 General & Plastic Surgery devices
Cleared
Jul 03, 2024
da Vinci Surgical System (IS5000)
NAY
System, Surgical, Computer Controlled Instrument
57d
Not Cleared
Jul 02, 2024
MagDI System
SAH
Magnetic Compression Anastomosis System
98d
Cleared
Jul 01, 2024
Valleylab™ SM Smoke Management Pencil with Edge™ Blade Electrode, 10’ (3m) (VSMP10)
GEI
Electrosurgical, Cutting & Coagulation & Accessories
123d
Cleared
Jul 01, 2024
Profound Matrix
GEI
Electrosurgical, Cutting & Coagulation & Accessories
174d
Not Cleared
Jul 01, 2024
BioHealx Anal Fistula Device
QML
Anal Fistula Closure Device
150d
Cleared
Jun 28, 2024
Lavieen
GEX
Powered Laser Surgical Instrument
42d
Cleared
Jun 28, 2024
XSense Cryoablation System with Cryoprobes
GEH
Unit, Cryosurgical, Accessories
88d
Cleared
Jun 28, 2024
Magseed Pro Magnetic Marker System
NEU
Marker, Radiographic, Implantable
287d
Cleared
Jun 26, 2024
Endoscopic Fluorescence Camera System (DPM-ENDOCAM-03PF)
GCJ
Laparoscope, General & Plastic Surgery
205d
Cleared
Jun 25, 2024
Allograft Delivery Device (OFAC-C)
FMF
Syringe, Piston
267d
Cleared
Jun 24, 2024
Picosecond Nd:YAG Laser (PICOCAREMAJESTY)
GEX
Powered Laser Surgical Instrument
60d
Cleared
Jun 24, 2024
Intense pulsed light therapy apparatus (FDA01, FDA02, FDA03, FDA04S, FDA05S, FDA06, FDA06S, FDA07, FDA07S, FDA08, FDA09S, FDA10S)
OHT
Light Based Over-the-counter Hair Removal
62d
Cleared
Jun 24, 2024
SILKRO
GEI
Electrosurgical, Cutting & Coagulation & Accessories
271d
Cleared
Jun 21, 2024
MOTUS PRO Family
GEX
Powered Laser Surgical Instrument
29d
Cleared
Jun 21, 2024
Ice Cooling IPL Hair Removal Device (UI07 BR, UI07 DB, UI07 BL, UI07 GP, UI07 PN, UI07 RE, UI07 WH, UI07 PW, UI20 BR, UI20 DB, UI20 BL, UI20GP, UI20 PN, UI20 RE, UI20 WH, UI20 PW)
OHT
Light Based Over-the-counter Hair Removal
106d
Cleared
Jun 20, 2024
Safety Lancet (XXXV)
FMK
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
14d
Cleared
Jun 20, 2024
IVYLASER Diode laser hair removal system (IVY-HR-Alloy)
GEX
Powered Laser Surgical Instrument
107d
Cleared
Jun 20, 2024
SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope)
GCJ
Laparoscope, General & Plastic Surgery
266d
Cleared
Jun 18, 2024
IPL Home Use Hair Removal Device (D-1199, D-T099, D-T018, D-T019, D-T003B, D-T003W, D-T018Y, D-T019Y, D-1196B, D-1196W, D-1196C, D-1196C1, D-T099K, D-T099KW, D-T012, D-T012W)
OHT
Light Based Over-the-counter Hair Removal
109d
Cleared
Jun 18, 2024
Irrisept Antimicrobial Wound Lavage
FRO
Dressing, Wound, Drug
111d
Cleared
Jun 18, 2024
Bladeless Trocar (E05, E10, E11, E12, ES05, ES10, ES12)
GCJ
Laparoscope, General & Plastic Surgery
145d
Cleared
Jun 18, 2024
Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM
KNW
Instrument, Biopsy
263d
Cleared
Jun 18, 2024
Ultrasonic Surgical System
LFL
Instrument, Ultrasonic Surgical
267d
Cleared
Jun 17, 2024
Medical Diode Laser (M2-GK)
GEX
Powered Laser Surgical Instrument
90d
Cleared
Jun 14, 2024
Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)
GEX
Powered Laser Surgical Instrument
28d
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