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
13721 General & Plastic Surgery devices
Cleared
Jun 29, 2015
BioZorb Marker
NEU
Marker, Radiographic, Implantable
203d
Cleared
Jun 26, 2015
XENOMEM WOUND MATRIX
KGN
Wound Dressing With Animal-derived Material(s)
451d
Cleared
Jun 25, 2015
Reprocessed LigaSure ImpactTM Curved, Large Jaw, Open Sealer/Divider
NUJ
Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
114d
Cleared
Jun 25, 2015
CRYOCARE CS SURGICAL SYSTEM
GEH
Unit, Cryosurgical, Accessories
422d
Cleared
Jun 25, 2015
MEDIHONEY WOUND DRESSINGS
FRO
Dressing, Wound, Drug
609d
Cleared
Jun 24, 2015
Habib EUS RFA
GEI
Electrosurgical, Cutting & Coagulation & Accessories
167d
Cleared
Jun 19, 2015
Tissue Removal Pouch
GCJ
Laparoscope, General & Plastic Surgery
86d
Cleared
Jun 19, 2015
miraDry System MD4000
OUB
Instrument For Treatment Of Hyperhidrosis
121d
Cleared
Jun 19, 2015
XLR8 PLUS (XLR8+)
OMP
Negative Pressure Wound Therapy Powered Suction Pump
172d
Cleared
Jun 18, 2015
Spacemaker Pro Access and Dissector System
GCJ
Laparoscope, General & Plastic Surgery
29d
Cleared
Jun 18, 2015
NanoKnife System
OAB
Low Energy Direct Current Thermal Ablation System
153d
Cleared
Jun 18, 2015
iPulse Smooth Skin Gold Hair Removal System
OHT
Light Based Over-the-counter Hair Removal
241d
Cleared
Jun 17, 2015
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip
FZP
Clip, Implantable
63d
Cleared
Jun 17, 2015
truFreeze System
GEH
Unit, Cryosurgical, Accessories
72d
Cleared
Jun 17, 2015
VS3-IR-MMS System
OWN
Confocal Optical Imaging
163d
Cleared
Jun 17, 2015
Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor Matrix
FTM
Mesh, Surgical
415d
Cleared
Jun 16, 2015
Edwards Suture Fastening System
HCF
Instrument, Ligature Passing And Knot Tying
75d
Cleared
Jun 16, 2015
OsteoCool V-2 RF Ablation System
GEI
Electrosurgical, Cutting & Coagulation & Accessories
285d
Cleared
Jun 12, 2015
Invia Liberty Negative Pressure Wound Therapy System, Invia Liberty Tubing Set, Y-connector, Drain Adaptor, Invia Liberty Canisters
OMP
Negative Pressure Wound Therapy Powered Suction Pump
269d
Cleared
Jun 11, 2015
XP1000 RF
GEI
Electrosurgical, Cutting & Coagulation & Accessories
177d
Cleared
Jun 11, 2015
PANTHER Endo Linear Cutter Staplers with Single Use Loading Units
GDW
Staple, Implantable
272d
Cleared
Jun 10, 2015
LaparoVue
GCJ
Laparoscope, General & Plastic Surgery
96d
Cleared
Jun 09, 2015
extriCARE Negative Pressure Wound Therapy Gel Strip - 8pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 7pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 6pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 5pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 4pc
OMP
Negative Pressure Wound Therapy Powered Suction Pump
29d
Cleared
Jun 09, 2015
Capillus 272 Office Pro
OAP
Laser, Comb, Hair
92d
Cleared
Jun 08, 2015
Hemogrip Patch
QSY
Hemostatic Wound Dressing Without Thrombin Or Other Biologics
186d
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