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
1334 General & Plastic Surgery devices
Cleared
Jun 17, 2022
SPY Laparoscope
GCJ
Laparoscope, General & Plastic Surgery
51d
Cleared
Jun 09, 2022
Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet
FMK
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
28d
Cleared
Jun 08, 2022
Promisemed Heel Blood Lancet
FMK
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
27d
Cleared
Jun 01, 2022
IPL Hair Removal Device, Model(s): UI04A, UI04B, UI04C
OHT
Light Based Over-the-counter Hair Removal
58d
Cleared
May 31, 2022
Fibrillar Collagen Wound Dressing
KGN
Wound Dressing With Animal-derived Material(s)
236d
Cleared
May 25, 2022
Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019)
GEI
Electrosurgical, Cutting & Coagulation & Accessories
96d
Cleared
May 25, 2022
780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and Safelight Cable
GCJ
Laparoscope, General & Plastic Surgery
149d
Cleared
May 24, 2022
Medline General Surgery Tray
LRO
General Surgery Tray
207d
Cleared
May 13, 2022
Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)
NUJ
Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
88d
Cleared
May 13, 2022
Zone Specific AIM
GAT
Suture, Nonabsorbable, Synthetic, Polyethylene
109d
Cleared
May 06, 2022
Masimo O3 Regional Oximeter System
MUD
Oximeter, Tissue Saturation
130d
Cleared
May 05, 2022
GIA Auto Suture Stapler with DST Series Technology
GDW
Staple, Implantable
30d
Cleared
Apr 29, 2022
GIA Stapler with Tri-Staple Technology
GDW
Staple, Implantable
24d
Cleared
Apr 29, 2022
EEA Circular Stapler with Tri-Staple Technology
GDW
Staple, Implantable
24d
Cleared
Apr 28, 2022
Geistlich Wound Matrix PLUS
KGN
Wound Dressing With Animal-derived Material(s)
164d
Cleared
Apr 26, 2022
PERMALOOP Suture, PERMATAPE Suture
GAT
Suture, Nonabsorbable, Synthetic, Polyethylene
90d
Cleared
Apr 22, 2022
1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), 1688 4K Pendulum Camera Head (1688310130)
GCJ
Laparoscope, General & Plastic Surgery
25d
Cleared
Apr 22, 2022
PicoStar
GEX
Powered Laser Surgical Instrument
130d
Cleared
Apr 22, 2022
Promisemed Fine Biopsy Needle
KNW
Instrument, Biopsy
151d
Cleared
Apr 22, 2022
LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel
FRO
Dressing, Wound, Drug
372d
Cleared
Apr 15, 2022
mJOULE System and Accessories
GEX
Powered Laser Surgical Instrument
189d
Cleared
Apr 13, 2022
MCL 31 Dermablate System
GEX
Powered Laser Surgical Instrument
406d
Cleared
Apr 08, 2022
ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler
GAG
Stapler, Surgical
142d
Cleared
Apr 08, 2022
SCOUT BX Delivery System
NEU
Marker, Radiographic, Implantable
210d
Cleared
Mar 24, 2022
Erchonia Zerona Z-Bed
OLI
Fat Reducing Low Level Laser
29d
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