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
13714 General & Plastic Surgery devices
Cleared
Dec 23, 2015
L-Mesitran Dressing Family II- Soft and Tulle
FRO
Dressing, Wound, Drug
282d
Cleared
Dec 23, 2015
BTM Wound Dressing
QSZ
Absorbable Synthetic Wound Dressing
447d
Cleared
Dec 22, 2015
Nexodyn AOS Wound Care Solution
FRO
Dressing, Wound, Drug
235d
Cleared
Dec 22, 2015
RUBY STAR
GEX
Powered Laser Surgical Instrument
251d
Cleared
Dec 22, 2015
Cellvizio 100 Series System with Confocal Miniprobes
OWN
Confocal Optical Imaging
267d
Cleared
Dec 22, 2015
NeoLas
GEX
Powered Laser Surgical Instrument
281d
Cleared
Dec 22, 2015
BONDEASE TOPICAL SKIN ADHESIVE
MPN
Tissue Adhesive For The Topical Approximation Of Skin
596d
Cleared
Dec 21, 2015
Quanta Forte
GEX
Powered Laser Surgical Instrument
91d
Cleared
Dec 18, 2015
EDGE Arthroscopic Energy System, Arthroscopic Energy System Probes, Arthroscopic Energy System Wireless Footswitch, Arthroscopic Energy System Corded Footswitch, Arthroscopic Energy System Foot Control, Extension
GEI
Electrosurgical, Cutting & Coagulation & Accessories
11d
Cleared
Dec 18, 2015
CUSA Excel+
LFL
Instrument, Ultrasonic Surgical
276d
Not Cleared
Dec 18, 2015
Newa Skin Therapy System
PAY
Over-the-counter Radiofrequency Coagulation Device For Wrinkle Reduction
336d
Cleared
Dec 17, 2015
Beacon Tissue Marker (SE)
NEU
Marker, Radiographic, Implantable
44d
Cleared
Dec 17, 2015
Laser Dock
GEX
Powered Laser Surgical Instrument
93d
Cleared
Dec 17, 2015
PK AIM
GEI
Electrosurgical, Cutting & Coagulation & Accessories
132d
Cleared
Dec 17, 2015
UV Lamps for Indoor Tanning Devices
LEJ
Booth, Sun Tan
210d
Cleared
Dec 17, 2015
Next Science Wound Gel
FRO
Dressing, Wound, Drug
267d
Cleared
Dec 16, 2015
Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue Technology
NLQ
Single-use Reprocessed Ultrasonic Surgical Instruments
289d
Cleared
Dec 15, 2015
Alevicyn SG Antipruritic Gel
FRO
Dressing, Wound, Drug
70d
Cleared
Dec 15, 2015
8X-10-XXXX Camera System
GCJ
Laparoscope, General & Plastic Surgery
104d
Cleared
Dec 11, 2015
GORE SYNECOR Biomaterial
FTL
Mesh, Surgical, Polymeric
88d
Cleared
Dec 11, 2015
MicroSpot Handpiece
GEX
Powered Laser Surgical Instrument
130d
Cleared
Dec 09, 2015
da Vinci Xi Hasson Cone
GCJ
Laparoscope, General & Plastic Surgery
41d
Cleared
Dec 09, 2015
Biodesign Enterocutaneous Fistula Plug
FTM
Mesh, Surgical
268d
Cleared
Dec 08, 2015
neoV980 & neoV1470 Diode Lasers
GEX
Powered Laser Surgical Instrument
77d
Cleared
Dec 08, 2015
Cytal Wound Matrix
KGN
Wound Dressing With Animal-derived Material(s)
78d
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