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
13738 General & Plastic Surgery devices
Cleared
Jul 10, 2014
MARATHON NO STING LIQUID SKIN PROTECTANT
KMF
Bandage, Liquid
240d
Cleared
Jul 10, 2014
BLOSSOM SALINE DELIVERY ASSIST DEVICE
LCJ
Tissue Expander And Accessories
395d
Cleared
Jul 02, 2014
X-REPAIRSL
FTL
Mesh, Surgical, Polymeric
26d
Cleared
Jul 02, 2014
ICESPHERE 1.5 90 CRYOBLATION NEEDLE, ICESHPERE 1.5 CYOBLATION NEEDLE
GEH
Unit, Cryosurgical, Accessories
27d
Cleared
Jun 30, 2014
ZF 720
FSY
Light, Surgical, Ceiling Mounted
320d
Cleared
Jun 25, 2014
VENUS SWAN(MP)2
GEI
Electrosurgical, Cutting & Coagulation & Accessories
106d
Cleared
Jun 25, 2014
BONDILOXS TOPICAL HEMOSTATIC DRESSING
QSY
Hemostatic Wound Dressing Without Thrombin Or Other Biologics
334d
Cleared
Jun 23, 2014
SUPOLENE
GAT
Suture, Nonabsorbable, Synthetic, Polyethylene
59d
Cleared
Jun 23, 2014
CLIQ DV-300 ASPIRATOR
JCX
Apparatus, Suction, Ward Use, Portable, Ac-powered
83d
Cleared
Jun 20, 2014
ECHO TIP ULTRA FIDUCIAL NEEDLE
NEU
Marker, Radiographic, Implantable
28d
Cleared
Jun 20, 2014
SUREFLEX LITHOTRIPSY LASER FIBERS
GEX
Powered Laser Surgical Instrument
94d
Cleared
Jun 20, 2014
ULTHERA SYSTEM
OHV
Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
171d
Cleared
Jun 20, 2014
DIAPHRAGMATIC HERNIA GRAFT
OWV
Mesh, Surgical, Collagen, Diaphragmatic Hernia
268d
Cleared
Jun 19, 2014
MIROMATRIX WOUND MATRIX
KGN
Wound Dressing With Animal-derived Material(s)
111d
Cleared
Jun 19, 2014
TRUFREEZE SYSTEM
GEH
Unit, Cryosurgical, Accessories
239d
Cleared
Jun 19, 2014
HYDROLYZED COLLAGEN/AG WOUND GEL WITH SILVER
FRO
Dressing, Wound, Drug
276d
Cleared
Jun 17, 2014
ULTRA RENEW PLUS
OLP
Over-the-counter Powered Light Based Laser For Acne
280d
Cleared
Jun 16, 2014
ENDOSHIELD BURN PROTECTION SYSTEM
GEI
Electrosurgical, Cutting & Coagulation & Accessories
165d
Cleared
Jun 14, 2014
REPROCESSED HARMONIC SHEAR
NLQ
Single-use Reprocessed Ultrasonic Surgical Instruments
303d
Cleared
Jun 13, 2014
SU-POR SURGICAL IMPLANT
KKY
Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
112d
Cleared
Jun 12, 2014
WARTIE WART REMOVER
GEH
Unit, Cryosurgical, Accessories
122d
Cleared
Jun 12, 2014
GENISTRONG SINGLE-USE SPECIMEN RETRIEVAL BAG
GCJ
Laparoscope, General & Plastic Surgery
317d
Cleared
Jun 11, 2014
FLEX ENDOSCOPIC INSTRUMENTS
GCJ
Laparoscope, General & Plastic Surgery
89d
Cleared
Jun 10, 2014
FREEDOM INGUINAL HERNIA REPAIR IMPLANT-25MM/40MM/40MM WITH EXTENDED DISK
FTL
Mesh, Surgical, Polymeric
57d
Cleared
Jun 10, 2014
TOPAZ EZ MICRODEBRIDER COBLATION WAND WITH INTEGRATED FINGER SWITCH
GEI
Electrosurgical, Cutting & Coagulation & Accessories
98d
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