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
1338 General & Plastic Surgery devices
Cleared
Jul 28, 2021
Braun Silk.expert Mini
OHT
Light Based Over-the-counter Hair Removal
30d
Cleared
Jul 23, 2021
da Vinci SP Surgical System (SP1098)
NAY
System, Surgical, Computer Controlled Instrument
84d
Cleared
Jul 22, 2021
Arthrex SynergyID Endoscopic Imaging System
GCJ
Laparoscope, General & Plastic Surgery
317d
Cleared
Jul 14, 2021
Nexo-Gide Bilayer Collagen Membrane
FTM
Mesh, Surgical
229d
Cleared
Jul 12, 2021
InMode RF Pro System
GEI
Electrosurgical, Cutting & Coagulation & Accessories
143d
Cleared
Jul 09, 2021
BTL-899 FP
GEI
Electrosurgical, Cutting & Coagulation & Accessories
86d
Cleared
Jul 06, 2021
DEKA Motus AZ
GEX
Powered Laser Surgical Instrument
25d
Cleared
Jul 01, 2021
Avance Solo Negative Pressure Wound Therapy (NPWT) System
OMP
Negative Pressure Wound Therapy Powered Suction Pump
227d
Cleared
Jun 24, 2021
Werewolf+ Coblation System, Werewolf+ Controller, Werewolf Fastseal 6.0 Hemostasis Wand
GEI
Electrosurgical, Cutting & Coagulation & Accessories
133d
Cleared
Jun 23, 2021
da Vinci SP Surgical System (SP1098)
NAY
System, Surgical, Computer Controlled Instrument
30d
Cleared
Jun 04, 2021
Kendall NPWT Incision Management Device
OMP
Negative Pressure Wound Therapy Powered Suction Pump
302d
Cleared
Jun 03, 2021
SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)
GEX
Powered Laser Surgical Instrument
28d
Cleared
May 21, 2021
Harmonic Hand Piece, Blue, Harmonic Hand Piece, Gray
LFL
Instrument, Ultrasonic Surgical
24d
Cleared
May 17, 2021
Electrosurgical Generator ESG-400, Foot Switches, POWERSEAL Curved Jaw Sealer and Divider, Double Action
GEI
Electrosurgical, Cutting & Coagulation & Accessories
151d
Cleared
May 04, 2021
Medline Vacu-line Suction Aspirator
BTA
Pump, Portable, Aspiration (manual Or Powered)
197d
Cleared
Apr 28, 2021
Electrosurgical Generator ESG-410, Foot Switches, PK Cutting Forceps
GEI
Electrosurgical, Cutting & Coagulation & Accessories
173d
Cleared
Apr 26, 2021
da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System
NAY
System, Surgical, Computer Controlled Instrument
28d
Cleared
Apr 26, 2021
ERISE Laser handpiece
GEX
Powered Laser Surgical Instrument
259d
Cleared
Apr 15, 2021
Edge Insulated Blade Electrode
GEI
Electrosurgical, Cutting & Coagulation & Accessories
69d
Cleared
Apr 13, 2021
1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, AIM Laparoscopes
GCJ
Laparoscope, General & Plastic Surgery
90d
Cleared
Mar 31, 2021
EnCor Breast Biopsy Probe with Rinse Tube
KNW
Instrument, Biopsy
27d
Cleared
Mar 26, 2021
DermaV Laser System
GEX
Powered Laser Surgical Instrument
88d
Cleared
Mar 23, 2021
LigaSure Exact Dissector, Nano-coated
GEI
Electrosurgical, Cutting & Coagulation & Accessories
175d
Cleared
Mar 18, 2021
SDC3 HD Information Management System with Wireless Device Control Capability
GCJ
Laparoscope, General & Plastic Surgery
20d
Cleared
Mar 18, 2021
DYNATAPE Suture
GAT
Suture, Nonabsorbable, Synthetic, Polyethylene
142d
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