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
14011 General & Plastic Surgery devices
Cleared
May 21, 2001
LYRA SERIES SURGICAL LASER SYSTEM & ACCESSORIES
GEX
Powered Laser Surgical Instrument
62d
Cleared
May 21, 2001
MODIFICATION TO SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL
OXD
Mesh, Surgical, Non-absorbable, Staple Line Reinforcement
54d
Cleared
May 18, 2001
MEGABEAM/CERALAS NON STERILE FIBER OPTIC LASER DELIVERY SYSTEMS, MODEL 200,320,400 OR 600UM
GEX
Powered Laser Surgical Instrument
71d
Cleared
May 14, 2001
DENSTAT
GEI
Electrosurgical, Cutting & Coagulation & Accessories
87d
Cleared
May 14, 2001
ARTHREX FIBERWIRE, MODEL SPU-02NB-3800
GAT
Suture, Nonabsorbable, Synthetic, Polyethylene
69d
Cleared
May 14, 2001
MODIFICATION TO IMPLANTABLE CLIP
FZP
Clip, Implantable
21d
Cleared
May 11, 2001
BIOKNOTLESS ANCHOR
GAM
Suture, Absorbable, Synthetic, Polyglycolic Acid
260d
Cleared
May 07, 2001
XPS 3000 SYSTEM WITH RECIPROCATING ADAPTER AND SUCTION CANNULAE
QPB
System, Suction, Lipoplasty For Removal
62d
Cleared
May 03, 2001
TANTALUM BEADS - RADIOGRAPHIC MARKER
NEU
Marker, Radiographic, Implantable
87d
Cleared
May 03, 2001
SEEDNET, MODELS FP6T5, FP5T5, FP5T3
GEH
Unit, Cryosurgical, Accessories
30d
Cleared
May 02, 2001
KSEA SAWAHLE ELECTROMECHANICAL MORCELLATOR
GCJ
Laparoscope, General & Plastic Surgery
86d
Cleared
May 01, 2001
LYRA G SERIES SURGICAL LASER SYSTEM (SL SERIES Q-SWITCHED ND:YAG CONFIGURATION)
GEX
Powered Laser Surgical Instrument
90d
Cleared
Apr 27, 2001
PROLENE (POLYPROPYLENE) 3D PATCH, NONABSORBABLE SYNTHETIC SURGICAL MESH
FTL
Mesh, Surgical, Polymeric
46d
Cleared
Apr 27, 2001
CANNULA, SURGICAL GENERAL & PLASTIC SURGERY, MODELR65-995, R65-995-1, R65-995-2, R65-997, R65-997-1
GCJ
Laparoscope, General & Plastic Surgery
43d
Cleared
Apr 23, 2001
MENTOR STERILE SALINE MAMMARY VOLUME SIZERS
MRD
Mammary Sizer
45d
Cleared
Apr 20, 2001
SONOTOME ULTRASONIC ASPIRATOR TIPS
LFL
Instrument, Ultrasonic Surgical
46d
Cleared
Apr 13, 2001
COBRA 1/2 FLEX SURGICAL PROBE, MODEL 1593X
GEI
Electrosurgical, Cutting & Coagulation & Accessories
14d
Cleared
Apr 11, 2001
CANDELA LONG PULSE ND:YAG
GEX
Powered Laser Surgical Instrument
89d
Cleared
Apr 10, 2001
MULTIFUCTION SUCTION IRRIGATION SYSTEM, EXISTING OF SUCTION IRRIGATION HANDLES, SUCTION IRRIGATION TUBES, AND TUBE SETS
GEI
Electrosurgical, Cutting & Coagulation & Accessories
284d
Cleared
Apr 10, 2001
DYONICS VISION 111 MOBILE VIDEO UNIT
GCJ
Laparoscope, General & Plastic Surgery
49d
Cleared
Apr 09, 2001
ULTRACISION HARMONIC SCALPEL COAGULATING SHEARS, MODEL LCSC5,LCSC1,CS23C,CS231,CS14C,CS141,LCSB5,LCSK5,LCS15,LCS16,CS150
GEI
Electrosurgical, Cutting & Coagulation & Accessories
196d
Cleared
Apr 09, 2001
BAYLIS MEDICAL RF PERFORATION PROBE, MODEL RFP-265
GEI
Electrosurgical, Cutting & Coagulation & Accessories
73d
Cleared
Apr 09, 2001
KSEA UNIVERSAL LAPAROMAT LAPAROSCOPIC SUCTION AND IRRIGATION PUMP
GCJ
Laparoscope, General & Plastic Surgery
42d
Cleared
Apr 04, 2001
IVS TUNNELLER
FTL
Mesh, Surgical, Polymeric
90d
Cleared
Apr 02, 2001
CYNOSURE PHOTOGENICA DL
GEX
Powered Laser Surgical Instrument
90d
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