FDA 510(k) General & Plastic Surgery Devices
FDA 510(k) General & Plastic Surgery Devices - Regulatory Overview
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
18288
Total
18243
Cleared
138d
Avg (2y)
1976
Since
13472 General & Plastic Surgery devices
Cleared
Nov 08, 2024
Plasonic (Plasonic)
GEI
Electrosurgical, Cutting & Coagulation & Accessories
200d
Cleared
Nov 08, 2024
Microdacyn Hydrogel
FRO
Dressing, Wound, Drug
260d
Cleared
Nov 07, 2024
Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG)
OHT
Light Based Over-the-counter Hair Removal
69d
Cleared
Nov 07, 2024
Remanufactured EndoWrist ProGrasp Forceps (420093)
QSM
System, Surgical, Computer Controlled Instrument, Remanufactured
133d
Cleared
Nov 07, 2024
Trilogy Tissue Marker
NEU
Marker, Radiographic, Implantable
268d
Cleared
Nov 06, 2024
Compound W Skin Tag Remover
GEH
Unit, Cryosurgical, Accessories
50d
Cleared
Nov 06, 2024
Ice Cooling IPL Hair Removal Device (UIM20 GR, UIM20 BK, UIM20 SL, UIM20 CB, UIM20 WR)
OHT
Light Based Over-the-counter Hair Removal
117d
Cleared
Nov 05, 2024
gentleheel® Adult Incision Device
FMK
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
62d
Cleared
Nov 05, 2024
POTENZA
GEI
Electrosurgical, Cutting & Coagulation & Accessories
551d
Cleared
Nov 01, 2024
Legend X Desktop System
GEI
Electrosurgical, Cutting & Coagulation & Accessories
29d
Cleared
Nov 01, 2024
Breo Laser Hair Growth Comb (Scalp 3L)
OAP
Laser, Comb, Hair
59d
Cleared
Nov 01, 2024
ORTIV (ORTIV-BL, ORTIV-WH)
GEX
Powered Laser Surgical Instrument
147d
Cleared
Nov 01, 2024
Signia™ Circular Adapter (Standard Length) (SIGCIRSTND)
GAG
Stapler, Surgical
214d
Cleared
Oct 31, 2024
Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo
FRO
Dressing, Wound, Drug
31d
Cleared
Oct 30, 2024
Safety Lancet
FMK
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
57d
Cleared
Oct 30, 2024
Edison System
QGM
Focused Ultrasound System For Non-thermal, Mechanical Tissue Ablation
121d
Cleared
Oct 30, 2024
LAGIS Endoscopic Instruments - Grasper (DI-5670-33D, DI-5670-45D, DI-5716-33D, DI-5716-45D, DI-5719-33D, DI-5731-33D, DI-5731-45D, DI-5901-33D, DI-5901-45D)
GCJ
Laparoscope, General & Plastic Surgery
268d
Cleared
Oct 29, 2024
Mammotome AutoCore™ Single Insertion Core Biopsy System
KNW
Instrument, Biopsy
29d
Cleared
Oct 28, 2024
Sterile Lancets for Single Use
QRK
Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
55d
Cleared
Oct 28, 2024
Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)
OHS
Light Based Over The Counter Wrinkle Reduction
136d
Cleared
Oct 28, 2024
ECHELON 4000 60mm Compact Stapler (EC3D60C)
GDW
Staple, Implantable
144d
Cleared
Oct 25, 2024
Diamond Air+ (UI04A, UI04B, UI04C, UI04M, UI04G, UI04W)
OHT
Light Based Over-the-counter Hair Removal
28d
Cleared
Oct 25, 2024
Freeze Point & Private Label Versions
GEH
Unit, Cryosurgical, Accessories
52d
Not Cleared
Oct 25, 2024
Dexter L6 System
SDD
Electromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile Field
315d
Cleared
Oct 24, 2024
MagDI System (MAG-01, DS-01)
SAH
Magnetic Compression Anastomosis System
99d
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