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
18368
Total
18322
Cleared
136d
Avg (2y)
1976
Since
18368 General & Plastic Surgery devices
Cleared
May 13, 2020
308nm Excimer System
FTC
Light, Ultraviolet, Dermatological
232d
Cleared
May 11, 2020
Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11
GEI
Electrosurgical, Cutting & Coagulation & Accessories
41d
Cleared
May 11, 2020
ArtiSential Laparoscopic Instrument-Electrodes
GEI
Electrosurgical, Cutting & Coagulation & Accessories
73d
Cleared
May 11, 2020
PuraDERM Gel
FRO
Dressing, Wound, Drug
188d
Cleared
May 09, 2020
Dermalux Tri-Wave MD
GEX
Powered Laser Surgical Instrument
58d
Cleared
May 07, 2020
HET Bipolar Electrocautery Forceps, HET Bipolar Electrocautery Monitor
GEI
Electrosurgical, Cutting & Coagulation & Accessories
106d
Cleared
May 06, 2020
RFID Localization System
NEU
Marker, Radiographic, Implantable
169d
Cleared
May 04, 2020
Anscare SIMO Negative Pressure Wound Therapy (NPWT) System
OKO
Negative Pressure Wound Therapy Non-powered Suction Apparatus
168d
Cleared
May 01, 2020
O-Genesis Graft Delivery System
FMF
Syringe, Piston
53d
Cleared
May 01, 2020
PDT-FACE
OLP
Over-the-counter Powered Light Based Laser For Acne
252d
Cleared
Apr 30, 2020
ClickClean
GCJ
Laparoscope, General & Plastic Surgery
27d
Cleared
Apr 30, 2020
Medical Non-Ablative Fractional Laser Systems
ONG
Powered Laser Surgical Instrument With Microbeamfractional Output
245d
Cleared
Apr 29, 2020
da Vinci Xi Surgical System, da Vinci X Surgical System
NAY
System, Surgical, Computer Controlled Instrument
212d
Cleared
Apr 29, 2020
PELNAC Bilayer Wound Matrix
KGN
Wound Dressing With Animal-derived Material(s)
279d
Cleared
Apr 29, 2020
GelPOINT Mini Advanced Access Platform
GCJ
Laparoscope, General & Plastic Surgery
292d
Cleared
Apr 24, 2020
MT One
GEX
Powered Laser Surgical Instrument
203d
Cleared
Apr 23, 2020
QuikClot Control+
POD
Temporary, Internal Use Hemostatic
91d
Cleared
Apr 22, 2020
SYLFIRM X
GEI
Electrosurgical, Cutting & Coagulation & Accessories
89d
Cleared
Apr 22, 2020
Dermapose Access
QPB
System, Suction, Lipoplasty For Removal
90d
Cleared
Apr 21, 2020
DANNIK Specimen Retrieval System with deployment mechanism, DANNIK Specimen Retrieval System (Bag Only)
GCJ
Laparoscope, General & Plastic Surgery
102d
Cleared
Apr 21, 2020
Pristine Scope
GCJ
Laparoscope, General & Plastic Surgery
158d
Cleared
Apr 20, 2020
CarpX
GEI
Electrosurgical, Cutting & Coagulation & Accessories
48d
Cleared
Apr 17, 2020
Diode Laser Therapy Device
GEX
Powered Laser Surgical Instrument
87d
Cleared
Apr 17, 2020
Irradiation Cosmetic Device
OAP
Laser, Comb, Hair
213d
Cleared
Apr 15, 2020
7 mm Extended Length Endoscope
GCJ
Laparoscope, General & Plastic Surgery
271d
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