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
1318 General & Plastic Surgery devices
Cleared
Aug 28, 2024
da Vinci Handheld Camera
GCJ
Laparoscope, General & Plastic Surgery
58d
Cleared
Aug 26, 2024
FiAPC plus probes
GEI
Electrosurgical, Cutting & Coagulation & Accessories
45d
Cleared
Aug 23, 2024
LightWalker Laser System Family
GEX
Powered Laser Surgical Instrument
28d
Cleared
Aug 21, 2024
Fraxel® FTX Laser System
GEX
Powered Laser Surgical Instrument
30d
Cleared
Aug 21, 2024
Kerecis Parvus (50207)
KGN
Wound Dressing With Animal-derived Material(s)
124d
Cleared
Aug 21, 2024
VERSA Negative Pressure Wound Therapy System (VCMPP-100)
OMP
Negative Pressure Wound Therapy Powered Suction Pump
125d
Cleared
Aug 21, 2024
MULA (K2-A1)
ONF
Powered Light Based Non-laser Surgical Instrument With Thermal Effect
201d
Cleared
Aug 21, 2024
Foundation Dermal Regeneration Scaffold Plus (DRS+) Duo
FRO
Dressing, Wound, Drug
202d
Cleared
Aug 20, 2024
MedtFine Safety Lancet
FMK
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
54d
Cleared
Aug 20, 2024
Luna 4 plus
OHS
Light Based Over The Counter Wrinkle Reduction
120d
Cleared
Aug 20, 2024
CUTIVA(TM) Topical Skin Adhesive (RM-1700)
MPN
Tissue Adhesive For The Topical Approximation Of Skin
237d
Cleared
Aug 19, 2024
Histolog® Scanner (Hardware 2.4, Software 3.3)
OWN
Confocal Optical Imaging
105d
Cleared
Aug 19, 2024
Negative Pressure Wound Therapy Device (V-Move, V-Grand)
OMP
Negative Pressure Wound Therapy Powered Suction Pump
126d
Cleared
Aug 16, 2024
Avicenna Roboflex
FGB
Ureteroscope And Accessories, Flexible/rigid
273d
Cleared
Aug 15, 2024
MICROLET®NEXT Lancet
QRK
Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
55d
Cleared
Aug 15, 2024
Medifun Safety Lancet ( MSL1 series)
FMK
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
58d
Cleared
Aug 15, 2024
NPseal (20 and 25)
OKO
Negative Pressure Wound Therapy Non-powered Suction Apparatus
78d
Cleared
Aug 15, 2024
Connected OR Hub with Device and Voice Control
GCJ
Laparoscope, General & Plastic Surgery
90d
Cleared
Aug 14, 2024
TRAUMAGEL®
QSY
Hemostatic Wound Dressing Without Thrombin Or Other Biologics
152d
Cleared
Aug 13, 2024
SUPER VELOCE
GEX
Powered Laser Surgical Instrument
61d
Cleared
Aug 13, 2024
Diode Laser Therapy Device (DF-DIODE LASER-S1)
GEX
Powered Laser Surgical Instrument
74d
Cleared
Aug 12, 2024
Eneka Selectif
GEX
Powered Laser Surgical Instrument
63d
Cleared
Aug 12, 2024
Medical Monitor (32HR734S)
GCJ
Laparoscope, General & Plastic Surgery
87d
Cleared
Aug 09, 2024
HyperSuture All Blue Extension Line
GAT
Suture, Nonabsorbable, Synthetic, Polyethylene
86d
Cleared
Aug 09, 2024
ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)
KNW
Instrument, Biopsy
154d
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