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
18256
Total
18211
Cleared
136d
Avg (2y)
1976
Since
7638 General & Plastic Surgery devices
Cleared
Jun 09, 2011
ATRICURE DISSECTOR
FTD
Lamp, Surgical
58d
Cleared
Jun 08, 2011
ENDOPATH ETS 35MM ENDOSCOPIC LINEAR CUTTER AND RELOADS, AND ETS-FLEX 35MM ENDOSCOPIC ARTICULATING LINEAR CUTTER AND RELO
GDW
Staple, Implantable
49d
Cleared
May 26, 2011
ATRICURE CRYO MODULE
GEH
Unit, Cryosurgical, Accessories
41d
Cleared
May 24, 2011
SORBAFIX (TM) ABSORBABLE FIXATION SYSTEM, PERMAFIX (TM) FIXATION SYSTEM
GDW
Staple, Implantable
29d
Cleared
May 19, 2011
SYNTHES HEMOSTATIC BONE PUTTY (HBP)
MTJ
Wax, Bone
140d
Cleared
May 13, 2011
ANGIODYNAMICS, INC. VENACURE 1470 LASER
GEX
Powered Laser Surgical Instrument
108d
Cleared
May 10, 2011
TORNIER BIOFIBER SCAFFOLD
FTL
Mesh, Surgical, Polymeric
228d
Cleared
May 02, 2011
DURAFIBER AG
FRO
Dressing, Wound, Drug
126d
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 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 01, 2011
VENTRALIGHT (TM) ST MESH WITH ECHO PS (TM) POSITIONING SYSTEM
FTL
Mesh, Surgical, Polymeric
9d
Cleared
Mar 29, 2011
FLEXIVA TRACTIP
GEX
Powered Laser Surgical Instrument
18d
Cleared
Mar 28, 2011
ACCUTRAC
GEX
Powered Laser Surgical Instrument
17d
Cleared
Mar 25, 2011
ECHELON FLEX 45 / 60 POWERED ARTICULATING ENDOSCOPIC LINEAR CUTTER
GDW
Staple, Implantable
43d
Cleared
Mar 23, 2011
CELSTAT
QSY
Hemostatic Wound Dressing Without Thrombin Or Other Biologics
141d
Cleared
Mar 23, 2011
VENTRALEX ST HERNIA PATCH
FTL
Mesh, Surgical, Polymeric
257d
Cleared
Mar 23, 2011
VENTRIO ST HERNIA PATCH
FTL
Mesh, Surgical, Polymeric
257d
Cleared
Mar 04, 2011
PARIETEX PROGRIP
FTL
Mesh, Surgical, Polymeric
77d
Cleared
Feb 16, 2011
CONMED R SABRE GENESIS TM ELECTROSURGICAL UNIT
GEI
Electrosurgical, Cutting & Coagulation & Accessories
62d
Cleared
Feb 15, 2011
SIROLASER ADVANCE, SIROLASER XTEND, SIROLASER XTEND UPGRADED, FONALASER
GEX
Powered Laser Surgical Instrument
54d
Cleared
Feb 15, 2011
ORTHOSTAT BONE HEMOSTAT MATRIX APPLICATOR
MTJ
Wax, Bone
144d
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