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
1328 General & Plastic Surgery devices
Cleared
Feb 28, 2023
HARMONIC 700 Shears
LFL
Instrument, Ultrasonic Surgical
252d
Cleared
Feb 24, 2023
babyLance Safety Heelstick (BLM, BLN, BLP)
FMK
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
58d
Cleared
Feb 23, 2023
1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000)
GCJ
Laparoscope, General & Plastic Surgery
28d
Cleared
Feb 23, 2023
Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source
GCJ
Laparoscope, General & Plastic Surgery
266d
Cleared
Feb 22, 2023
The Alma Soprano Titanium
GEX
Powered Laser Surgical Instrument
9d
Cleared
Feb 22, 2023
Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™ Circular Adapters)
GAG
Stapler, Surgical
261d
Cleared
Feb 21, 2023
Verifine® Ease Lancing Device, Verifine® Lancing Device
QRL
Multiple Use Blood Lancet For Single Patient Use Only
77d
Cleared
Feb 18, 2023
FloNavi Endoscopic Fluorescence Imaging System
GCJ
Laparoscope, General & Plastic Surgery
236d
Cleared
Feb 17, 2023
troCarWash™ System
OCX
Endoscopic Irrigation/suction System
164d
Cleared
Feb 16, 2023
Sonopet 1Q 3 7cm 1Q Large
LFL
Instrument, Ultrasonic Surgical
63d
Cleared
Feb 14, 2023
Creo Electrosurgical System with NP1 Instrument
NEY
System, Ablation, Microwave And Accessories
250d
Cleared
Feb 02, 2023
Image Processing Unit, Model: OPTO-CAM104K, Camera Head, Model: OPTO-CHD104KH
GCJ
Laparoscope, General & Plastic Surgery
226d
Cleared
Feb 01, 2023
LED Light Therapy Device, KN-7000L
GEX
Powered Laser Surgical Instrument
142d
Cleared
Jan 30, 2023
PHMB Wound Dressing
FRO
Dressing, Wound, Drug
249d
Cleared
Jan 26, 2023
PALLAS Premium
GEX
Powered Laser Surgical Instrument
56d
Cleared
Jan 23, 2023
LigaSure™ XP Maryland Jaw Sealer/Divider
GEI
Electrosurgical, Cutting & Coagulation & Accessories
108d
Cleared
Jan 20, 2023
Duetto Suprema
GEX
Powered Laser Surgical Instrument
72d
Cleared
Jan 19, 2023
AvalancheLase Family
GEX
Powered Laser Surgical Instrument
55d
Cleared
Jan 17, 2023
Ag Foam Dressing Non-Adhesive (OTC)
FRO
Dressing, Wound, Drug
215d
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
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