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
13830 General & Plastic Surgery devices
Cleared
May 18, 2011
TIGERPAW SYSTEM II
GDW
Staple, Implantable
30d
Cleared
May 18, 2011
SHASER IPL HAIR REMOVAL SYSTEM
ONF
Powered Light Based Non-laser Surgical Instrument With Thermal Effect
166d
Cleared
May 17, 2011
CHITOGAUZE FUSION
QSY
Hemostatic Wound Dressing Without Thrombin Or Other Biologics
21d
Cleared
May 13, 2011
VITAMESH (TM) BLUE LIGHTWEIGHT MACROPOROUS PP SURGICAL MESH
FTL
Mesh, Surgical, Polymeric
22d
Cleared
May 13, 2011
ANGIODYNAMICS, INC. VENACURE 1470 LASER
GEX
Powered Laser Surgical Instrument
108d
Cleared
May 10, 2011
CELOX RAPID GAUZE
QSY
Hemostatic Wound Dressing Without Thrombin Or Other Biologics
89d
Cleared
May 10, 2011
WEXLER ENDOSCOPE ACCESSORIES
GCJ
Laparoscope, General & Plastic Surgery
112d
Cleared
May 10, 2011
TORNIER BIOFIBER SCAFFOLD
FTL
Mesh, Surgical, Polymeric
228d
Cleared
May 06, 2011
DIAMOND-FLEX(R) GRASPERS
GCJ
Laparoscope, General & Plastic Surgery
98d
Cleared
May 06, 2011
UNIMAX SPECIMEN RETRIEVAL SYSTEM
GCJ
Laparoscope, General & Plastic Surgery
158d
Cleared
May 03, 2011
CLEAR+BRILLIANT LASER SYSTEM
ONG
Powered Laser Surgical Instrument With Microbeamfractional Output
85d
Cleared
May 02, 2011
DURAFIBER AG
FRO
Dressing, Wound, Drug
126d
Cleared
Apr 28, 2011
PERIOPATCH
OLR
Oral Wound Dressing
42d
Cleared
Apr 28, 2011
SPECTRA LASER SYSTEM
GEX
Powered Laser Surgical Instrument
156d
Cleared
Apr 27, 2011
TRIPLEX ER. YAG / ND: YAG SYSTEM
GEX
Powered Laser Surgical Instrument
64d
Cleared
Apr 22, 2011
VENX REVOLUTION
GAH
Stylet, Surgical, General & Plastic Surgery
74d
Cleared
Apr 19, 2011
PARIETEX OPTIMIZED COMPOSITE MESH (PCO-OSX REFERENCES)
FTL
Mesh, Surgical, Polymeric
26d
Cleared
Apr 19, 2011
PARIETEX OPTIMIZED COMPOSTIE MESH
FTL
Mesh, Surgical, Polymeric
26d
Cleared
Apr 19, 2011
TRIXEL CO2 LASER
GEX
Powered Laser Surgical Instrument
63d
Cleared
Apr 08, 2011
APEX ER. YAG / IPL SYSTEM
GEX
Powered Laser Surgical Instrument
65d
Cleared
Apr 08, 2011
REUSABLE PPH CIRCULAR STAPLER HANDLE, PPH CIRCULAR STAPLER RELOAD & ACCESSORY SET
GDW
Staple, Implantable
113d
Cleared
Apr 08, 2011
D-STAT DRY SILVER
QSX
Hemostatic Wound Dressing With Thrombin Or Other Biologics
245d
Cleared
Apr 08, 2011
INTUITIVE SURGICAL DA VINCI S SURGICAL SYSTEM WITH DA VINCI CONNECT & DA VINCI ONSITE, MODEL IS2000
NAY
System, Surgical, Computer Controlled Instrument
305d
Cleared
Apr 06, 2011
PRONTOSAN WOUND IRRIGATION SOLUTION
FRO
Dressing, Wound, Drug
20d
Cleared
Apr 06, 2011
VELA XL
GEX
Powered Laser Surgical Instrument
112d
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