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
13846 General & Plastic Surgery devices
Cleared
May 27, 2009
XYLOS POROUS SURGICAL MESH
FTM
Mesh, Surgical
57d
Cleared
May 22, 2009
FREEHAND
GCJ
Laparoscope, General & Plastic Surgery
101d
Cleared
May 20, 2009
APLION TOPICAL CARE SYSTEM
NAD
Dressing, Wound, Occlusive
30d
Cleared
May 20, 2009
OCULUS MICROCYN WOUND GEL
FRO
Dressing, Wound, Drug
62d
Cleared
May 20, 2009
SUPRATHEL WOUND AND BURN DRESSING
QSZ
Absorbable Synthetic Wound Dressing
118d
Cleared
May 20, 2009
ZELTIQ SYSTEM
GEX
Powered Laser Surgical Instrument
126d
Cleared
May 18, 2009
INTELLIGENT POWER UNIT, INTELLIGENT CONSOLE, INTELLIGENT DELIVERY SYSTEM, INTELLIGENT SURGICAL INSTRUMENT
GDW
Staple, Implantable
21d
Cleared
May 18, 2009
ALGISEAL PAD
QSY
Hemostatic Wound Dressing Without Thrombin Or Other Biologics
25d
Cleared
May 18, 2009
LIPOKIT WITH DISPOSABLE 50CC AFT SYRINGE, MODEL ZLK-100
MUU
System, Suction, Lipoplasty
178d
Cleared
May 15, 2009
LOTUS II PULSED ER: YAG LASER SYSTEM
GEX
Powered Laser Surgical Instrument
192d
Cleared
May 14, 2009
ABTHERA OPEN ABDOMEN DRESSING, MODEL: M8275026
FTL
Mesh, Surgical, Polymeric
78d
Cleared
May 14, 2009
AUTOSUTURE PROTACK
OCW
Endoscopic Tissue Approximation Device
80d
Cleared
May 14, 2009
AONGEN COLLAGEN MATRIX
KGN
Wound Dressing With Animal-derived Material(s)
412d
Cleared
May 13, 2009
ELITE MPX LASER SYSTEM WITH CRYO C
GEX
Powered Laser Surgical Instrument
21d
Cleared
May 11, 2009
SOCKIT! AND MCMERLIN DERMAL WOUND GEL
FRO
Dressing, Wound, Drug
117d
Cleared
May 11, 2009
REFINE LIFT SYSTEM
FTL
Mesh, Surgical, Polymeric
203d
Cleared
May 08, 2009
CUSA SHEAR TIP, AN ACCESSORY OF THE CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM
LFL
Instrument, Ultrasonic Surgical
39d
Cleared
May 07, 2009
INNOPORT LAPAROSCOPIC ACCESS DEVICE
GCJ
Laparoscope, General & Plastic Surgery
52d
Cleared
May 07, 2009
ELLMAN INTERNATIONAL NON-ABLATIVE TECHNIQUE FOR SURGITRON IEC
GEI
Electrosurgical, Cutting & Coagulation & Accessories
223d
Cleared
May 07, 2009
INTUITIVE SURGICAL ENDOWRIST ONE HOT SHEARS INSTRUMENT
NAY
System, Surgical, Computer Controlled Instrument
251d
Cleared
May 06, 2009
PARIETEX MONOFILAMENT POLYESTER MESH
FTL
Mesh, Surgical, Polymeric
37d
Cleared
May 06, 2009
LARIAT II SUTURE DELIVERY DEVICE
GAT
Suture, Nonabsorbable, Synthetic, Polyethylene
78d
Cleared
May 05, 2009
ORTHADAPT PR
FTL
Mesh, Surgical, Polymeric
89d
Cleared
May 04, 2009
COVIDIEN SPORTS SURGERY AS MENISCAL REPAIR DEVICE WITH HIGH STRENGTH SUTURE
GAT
Suture, Nonabsorbable, Synthetic, Polyethylene
25d
Cleared
May 04, 2009
LUME 2 SYSTEM, MODEL GA0005000
GEX
Powered Laser Surgical Instrument
139d
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