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
13951 General & Plastic Surgery devices
Cleared
Jun 02, 2005
NONABSORBABLE (POLYETHYLENE TEREPHTHALATE) SURGICAL SUTURE
GAT
Suture, Nonabsorbable, Synthetic, Polyethylene
360d
Cleared
Jun 02, 2005
FT FIBER OPTIC DELIVERY SYSTEMS
GEX
Powered Laser Surgical Instrument
77d
Cleared
Jun 02, 2005
HARMONIC ACE CURVED SHEARS WITH PISTOL HANDLE AND HAND CONTROL, MODEL ACE23P, ACE36P
LFL
Instrument, Ultrasonic Surgical
38d
Cleared
Jun 01, 2005
ZENO
GEX
Powered Laser Surgical Instrument
175d
Cleared
Jun 01, 2005
MODIFICATION TO: MODIFIED USS POLYPROPYLENE SUTURE
GAW
Suture, Nonabsorbable, Synthetic, Polypropylene
47d
Cleared
Jun 01, 2005
REVOLIX AND REVOLIX JR
GEX
Powered Laser Surgical Instrument
27d
Cleared
May 27, 2005
MODIFICATION TO:SYNTHES (USA) TITANIUM WIRE
GAQ
Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
245d
Cleared
May 27, 2005
VANGUARD REPROCESSED ARTHROSCOPIC WANDS
NUJ
Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
190d
Cleared
May 27, 2005
SURGI-WRAP MAST BIORESORBABLE SHEET
FTL
Mesh, Surgical, Polymeric
106d
Cleared
May 27, 2005
ODYSSEY 2.4G, DENLASER ELITE, MODEL 002-00050
GEX
Powered Laser Surgical Instrument
94d
Cleared
May 26, 2005
V.A.C. GRANUFOAM SILVER PROTECTION DRESSING
OMP
Negative Pressure Wound Therapy Powered Suction Pump
111d
Cleared
May 25, 2005
SALUTE FIXATION SYSTEM
GDW
Staple, Implantable
76d
Cleared
May 25, 2005
SMITH & NEPHEW VULCAN ARTICULAR CARTILAGE PROBE, MODEL 721XXXX
GEI
Electrosurgical, Cutting & Coagulation & Accessories
44d
Cleared
May 20, 2005
MOTIFMESH SOFT TISSUE PATCH
FTL
Mesh, Surgical, Polymeric
65d
Cleared
May 19, 2005
SIS DERMAL AUGMENTATION STRAND
FTM
Mesh, Surgical
106d
Cleared
May 18, 2005
LIGHTWAVE INTEGRATED ELECTRODE ABLATOR AND LIGHT WAVE INTEGRATED ELECTRODE SUCTION ABLATOR
JOS
Electrode, Electrosurgical
35d
Cleared
May 18, 2005
EUTROCHAR
MDM
Instrument, Manual, Surgical, General Use
33d
Cleared
May 17, 2005
EPI-MAX
FRO
Dressing, Wound, Drug
389d
Cleared
May 17, 2005
DERMACYN WOUND IRRIGATION
FRO
Dressing, Wound, Drug
228d
Cleared
May 17, 2005
CELLERATION MIST THERAPY SYSTEM 5.1
NRB
Wound Cleaner, Ultrasound
118d
Cleared
May 17, 2005
ADVANCED TURBO DRIVE SYSTEM
GEY
Motor, Surgical Instrument, Ac-powered
77d
Cleared
May 17, 2005
ENDOPATH ENDOCUTTER 60 ENDOSCOPIC LINEAR CUTTER
GDW
Staple, Implantable
27d
Cleared
May 16, 2005
REPOL ANGIMESH, ANGIMESH PRE, FOLDED MESH, REPOL PLUG BASIC, REPOL PLUG CAP, REPOL PLUG FLOWER AND WINGS MESH
FTL
Mesh, Surgical, Polymeric
180d
Cleared
May 16, 2005
POLYPROPILENE SURGICAL SUTURES
GAW
Suture, Nonabsorbable, Synthetic, Polypropylene
165d
Cleared
May 16, 2005
ARMAND ENDOSCOPE HOLDER
GCJ
Laparoscope, General & Plastic Surgery
126d
Looking for a specific general & plastic surgery device? Search by device name, K-number or manufacturer.
Search all General & Plastic Surgery 510(k) devices