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
Oct 25, 2017
CleanCision Wound Retraction and Protection System
PQI
Wound Retraction And Protection System
103d
Cleared
Oct 23, 2017
gi-4000 Electrosurgical Generator
GEI
Electrosurgical, Cutting & Coagulation & Accessories
35d
Cleared
Oct 23, 2017
Monosyn Quick Synthetic Absorbable Surgical Suture
GAM
Suture, Absorbable, Synthetic, Polyglycolic Acid
202d
Cleared
Oct 20, 2017
NeuroBlate System
GEX
Powered Laser Surgical Instrument
29d
Cleared
Oct 20, 2017
FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture
GAP
Suture, Nonabsorbable, Silk
95d
Cleared
Oct 20, 2017
Ultimate Contour, Ultimate Contour Mini
PBX
Massager, Vacuum, Radio Frequency Induced Heat
193d
Cleared
Oct 19, 2017
Discovery Pico, Discovery Pico Plus
GEX
Powered Laser Surgical Instrument
73d
Cleared
Oct 18, 2017
ANCHOR Tissue Retrieval System
GCJ
Laparoscope, General & Plastic Surgery
22d
Cleared
Oct 18, 2017
Medline ReNewal Reprocessed Stryker SERF AS Energy Probes
NUJ
Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
48d
Cleared
Oct 17, 2017
585
GEX
Powered Laser Surgical Instrument
88d
Cleared
Oct 17, 2017
X-SURGE
GEI
Electrosurgical, Cutting & Coagulation & Accessories
126d
Cleared
Oct 16, 2017
HylaGuard Moisturizing Cream
MGQ
Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic
115d
Cleared
Oct 13, 2017
micro IPL
OHT
Light Based Over-the-counter Hair Removal
86d
Cleared
Oct 13, 2017
CELFIRM
GEI
Electrosurgical, Cutting & Coagulation & Accessories
100d
Cleared
Oct 13, 2017
Exciplex308nm
FTC
Light, Ultraviolet, Dermatological
127d
Cleared
Oct 13, 2017
PAL Multi-Use Cannulas and PAL Manual Wand
QPB
System, Suction, Lipoplasty For Removal
165d
Cleared
Oct 13, 2017
Senhance Surgical Robotic System
NAY
System, Surgical, Computer Controlled Instrument
182d
Cleared
Oct 11, 2017
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2)
FZP
Clip, Implantable
29d
Cleared
Oct 10, 2017
InMode RF System
GEI
Electrosurgical, Cutting & Coagulation & Accessories
132d
Cleared
Oct 06, 2017
Endoscopic Applicator, 41 cm
GCJ
Laparoscope, General & Plastic Surgery
31d
Cleared
Oct 06, 2017
MT ONE
GEX
Powered Laser Surgical Instrument
57d
Cleared
Oct 06, 2017
MicroMatrix
KGN
Wound Dressing With Animal-derived Material(s)
59d
Cleared
Oct 05, 2017
PROLENE Soft Polypropylene Mesh
FTL
Mesh, Surgical, Polymeric
86d
Cleared
Oct 04, 2017
Ultrasonic Generator
LFL
Instrument, Ultrasonic Surgical
28d
Cleared
Oct 04, 2017
HelixAR Electrosurgical Generator with Argon Beam Coagulation, HelixAR Mobile Pedestal
GEI
Electrosurgical, Cutting & Coagulation & Accessories
29d
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