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
13531 General & Plastic Surgery devices
Cleared
Sep 02, 2022
DURAMESH Mesh Suture
GAW
Suture, Nonabsorbable, Synthetic, Polypropylene
500d
Cleared
Sep 01, 2022
Erchonia GVL
NHN
Powered Light Based Laser Non-thermal Instrument With Non-heating Effect For Adjunctive Use In Pain Therapy
57d
Cleared
Sep 01, 2022
Ambient HipVac 50 Wand with Integrated Finger Switches, RF20000 COBLATION System, WEREWOLF COBLATION System, WEREWOLF+ COBLATION System
GEI
Electrosurgical, Cutting & Coagulation & Accessories
185d
Cleared
Sep 01, 2022
FOX 810, FOX 980
GEX
Powered Laser Surgical Instrument
189d
Cleared
Sep 01, 2022
Soteria Bed Barrier
QTV
Mattress And Bed Deck Cover (medical Purposes)
786d
Cleared
Aug 31, 2022
IPL sapphire ice cooling hair remove device
OHT
Light Based Over-the-counter Hair Removal
86d
Cleared
Aug 31, 2022
Disposable Blood Lancet
QRK
Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
100d
Cleared
Aug 30, 2022
Lancing device
QRL
Multiple Use Blood Lancet For Single Patient Use Only
56d
Cleared
Aug 26, 2022
NEOVEIL Staple Line Reinforcement
OXC
Mesh, Surgical, Absorbable, Staple Line Reinforcement
95d
Cleared
Aug 26, 2022
Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device
FTL
Mesh, Surgical, Polymeric
226d
Cleared
Aug 26, 2022
Beamer AVEO Electrosurgical Generator, Beamer AVEO Argon Module, Beamer AVEO Cart, Beamer AVEO Wired Foot Pedal, Beamer AVEO Argon Pressure Reducer
GEI
Electrosurgical, Cutting & Coagulation & Accessories
242d
Cleared
Aug 25, 2022
LapBox Tissue Containment Removal System
GCJ
Laparoscope, General & Plastic Surgery
105d
Cleared
Aug 25, 2022
Apollo Duet (Model : APD-4000)
PBX
Massager, Vacuum, Radio Frequency Induced Heat
402d
Cleared
Aug 24, 2022
V-Laser
GEX
Powered Laser Surgical Instrument
100d
Cleared
Aug 23, 2022
OneTouch Delica Plus Lancing System
QRL
Multiple Use Blood Lancet For Single Patient Use Only
88d
Cleared
Aug 23, 2022
Picosecond Laser System (Model PS10-A and PS10-B)
GEX
Powered Laser Surgical Instrument
204d
Cleared
Aug 22, 2022
CUSA Clarity Ultrasonic Surgical Aspirator System
LFL
Instrument, Ultrasonic Surgical
60d
Cleared
Aug 22, 2022
SafetiHeel, MediHeel, Novaplus
FMK
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
81d
Cleared
Aug 22, 2022
Arthrex FiberTape and TigerTape Cerclage Sutures
HTN
Washer, Bolt Nut
91d
Cleared
Aug 19, 2022
1688 4K Camera System with Advanced Imaging Modality
GCJ
Laparoscope, General & Plastic Surgery
32d
Cleared
Aug 19, 2022
Bonvadis Topical Cream
FRO
Dressing, Wound, Drug
371d
Cleared
Aug 18, 2022
truFreeze Console, PN CC301
GEH
Unit, Cryosurgical, Accessories
20d
Cleared
Aug 18, 2022
Miro3D Wound Matrix
KGN
Wound Dressing With Animal-derived Material(s)
85d
Cleared
Aug 17, 2022
Disposable Blood Lancets
QRL
Multiple Use Blood Lancet For Single Patient Use Only
188d
Cleared
Aug 15, 2022
da Vinci X/Xi (IS4200/IS4000) 8mm Reusable Instruments
NAY
System, Surgical, Computer Controlled Instrument
230d
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