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
Jan 13, 2023
Light-Guide Cables
HBI
Illuminator, Fiberoptic, Surgical Field
93d
Cleared
Jan 13, 2023
Antimicrobial gauze sponge dressing
FRO
Dressing, Wound, Drug
211d
Cleared
Jan 13, 2023
Scivita 4KINSIGHT ICG Imaging System
GCJ
Laparoscope, General & Plastic Surgery
256d
Cleared
Jan 04, 2023
SmoothCool HR System
GEX
Powered Laser Surgical Instrument
26d
Cleared
Jan 04, 2023
DEKA HELIX
GEX
Powered Laser Surgical Instrument
163d
Cleared
Dec 20, 2022
HOPKINS Telescopes
GCJ
Laparoscope, General & Plastic Surgery
259d
Cleared
Dec 16, 2022
BD Microtainer® Contact-Activated Lancets
FMK
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
57d
Cleared
Dec 09, 2022
120V Neptune S Rover (0711-001-000)
JCX
Apparatus, Suction, Ward Use, Portable, Ac-powered
108d
Cleared
Dec 02, 2022
truFreeze Console, PN CC301
GEH
Unit, Cryosurgical, Accessories
28d
Cleared
Dec 02, 2022
Parietene Macroporous Mesh
FTL
Mesh, Surgical, Polymeric
46d
Cleared
Nov 30, 2022
EEA Circular Stapler with Tri-Staple Technology
GDW
Staple, Implantable
162d
Cleared
Nov 29, 2022
Signia™ Small Diameter Reloads Including Regular (Round) Tip Version
GDW
Staple, Implantable
89d
Cleared
Nov 23, 2022
LDE4 Lancing Device
QRL
Multiple Use Blood Lancet For Single Patient Use Only
82d
Cleared
Nov 22, 2022
da Vinci X Surgical System (IS4200), da Vinci Xi Surgical System (IS4000)
NAY
System, Surgical, Computer Controlled Instrument
53d
Cleared
Nov 22, 2022
Renasys Edge (66803126)
OMP
Negative Pressure Wound Therapy Powered Suction Pump
54d
Cleared
Nov 15, 2022
STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device
GAM
Suture, Absorbable, Synthetic, Polyglycolic Acid
152d
Cleared
Nov 10, 2022
H1
GCJ
Laparoscope, General & Plastic Surgery
84d
Cleared
Nov 03, 2022
truSculpt iD
GEI
Electrosurgical, Cutting & Coagulation & Accessories
31d
Cleared
Oct 27, 2022
Arthrex BioSuture
GAT
Suture, Nonabsorbable, Synthetic, Polyethylene
216d
Cleared
Oct 20, 2022
da Vinci Firefly Imaging System
NAY
System, Surgical, Computer Controlled Instrument
31d
Cleared
Oct 17, 2022
WavelinQ™ Generator
GEI
Electrosurgical, Cutting & Coagulation & Accessories
31d
Cleared
Oct 13, 2022
The Oligio
GEI
Electrosurgical, Cutting & Coagulation & Accessories
99d
Cleared
Oct 11, 2022
Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control
GCJ
Laparoscope, General & Plastic Surgery
88d
Cleared
Sep 30, 2022
Autosuture EEA Stapler / circular stapler with DST Series Technology / EEA Autosuture Circular Stapler with DST Series Technology / DST Series EEA Stapler / DST EEA
GDW
Staple, Implantable
178d
Cleared
Sep 26, 2022
RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device
QRL
Multiple Use Blood Lancet For Single Patient Use Only
168d
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