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
13656 General & Plastic Surgery devices
Cleared
Jun 12, 2017
Picocare
GEX
Powered Laser Surgical Instrument
255d
Cleared
Jun 08, 2017
BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider
GEI
Electrosurgical, Cutting & Coagulation & Accessories
59d
Cleared
Jun 08, 2017
Gentrix Surgical Matrix Thick
FTM
Mesh, Surgical
87d
Cleared
Jun 08, 2017
Novosyn Quick Absorbable Suture
GAM
Suture, Absorbable, Synthetic, Polyglycolic Acid
97d
Cleared
Jun 08, 2017
Laser Peripherals, LLC Family of Bare Laser Fibers
GEX
Powered Laser Surgical Instrument
122d
Cleared
Jun 08, 2017
NEXA Negative Pressure Wound Therapy System
OMP
Negative Pressure Wound Therapy Powered Suction Pump
262d
Cleared
Jun 07, 2017
SurgiMend PRS Meshed, Revize-X
OXH
Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery
29d
Cleared
Jun 06, 2017
Magnetic Surgical System
PNL
Magnetic Surgical System
22d
Cleared
Jun 06, 2017
CURVE Laser System
OLI
Fat Reducing Low Level Laser
90d
Cleared
Jun 02, 2017
Radiopaque Tissue Marker
NEU
Marker, Radiographic, Implantable
150d
Cleared
Jun 02, 2017
LS-5 ePTFE Suture
NBY
Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
161d
Cleared
Jun 02, 2017
KeraStat(R) Gel
KGN
Wound Dressing With Animal-derived Material(s)
245d
Cleared
Jun 01, 2017
Xenocor Xenoscope Laparoscopic System
GCJ
Laparoscope, General & Plastic Surgery
24d
Cleared
May 31, 2017
EndoWrist Stapler 45 System and Stapler 45 Reloads
NAY
System, Surgical, Computer Controlled Instrument
20d
Cleared
May 31, 2017
Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform, Soprano YAG Hand piece
GEX
Powered Laser Surgical Instrument
90d
Cleared
May 31, 2017
OptiFix AT Absorbable Fixation System with Articulating Technology - 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology - 15 Fasteners
GDW
Staple, Implantable
121d
Cleared
May 30, 2017
27HJ713S
GCJ
Laparoscope, General & Plastic Surgery
64d
Cleared
May 26, 2017
SutureTape
GAT
Suture, Nonabsorbable, Synthetic, Polyethylene
24d
Cleared
May 26, 2017
da Vinci X Surgical System
NAY
System, Surgical, Computer Controlled Instrument
24d
Cleared
May 25, 2017
KARL STORZ ICG Imaging System
OWN
Confocal Optical Imaging
28d
Cleared
May 25, 2017
PicoWay Laser System
GEX
Powered Laser Surgical Instrument
86d
Cleared
May 24, 2017
truFreeze System
GEH
Unit, Cryosurgical, Accessories
187d
Cleared
May 24, 2017
Cook Holmium Laser Fiber
GEX
Powered Laser Surgical Instrument
190d
Cleared
May 24, 2017
ACTION II Laser System
GEX
Powered Laser Surgical Instrument
190d
Cleared
May 23, 2017
Skylit Phototherapy System
FTC
Light, Ultraviolet, Dermatological
95d
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