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
13888 General & Plastic Surgery devices
Cleared
Aug 04, 2006
SOLARC / SOLRX HANDHELD ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY
FTC
Light, Ultraviolet, Dermatological
57d
Cleared
Aug 02, 2006
U-CLIP DEVICE, MODEL NC65
FZP
Clip, Implantable
13d
Cleared
Aug 02, 2006
BLOXX RAPID CLOTTING AGENT
QSY
Hemostatic Wound Dressing Without Thrombin Or Other Biologics
44d
Cleared
Aug 02, 2006
AGCEL WOUND DRESSING,AGCEL BURN DRESSING
FRO
Dressing, Wound, Drug
488d
Cleared
Aug 01, 2006
DORNIER MEDILAS H 20 LASER
GEX
Powered Laser Surgical Instrument
68d
Cleared
Aug 01, 2006
VNUS CLOSUREFAST CATHETER, MODELS CF7-7-60 AND CF7-7-100
GEI
Electrosurgical, Cutting & Coagulation & Accessories
76d
Cleared
Jul 31, 2006
FLEXVIEW SYSTEM
GCJ
Laparoscope, General & Plastic Surgery
11d
Cleared
Jul 31, 2006
COOLTOUCH VARIA ND:YAG LASER SYSTEM
GEX
Powered Laser Surgical Instrument
115d
Cleared
Jul 27, 2006
FLEX 10 MIS ABLATION PROBE, MODEL FLX10MI-05
NEY
System, Ablation, Microwave And Accessories
24d
Cleared
Jul 27, 2006
URGOTUL AG
FRO
Dressing, Wound, Drug
87d
Cleared
Jul 27, 2006
KSEA ROTOCUT G1 ELECTROMECHANICAL MORCELLATOR
GCJ
Laparoscope, General & Plastic Surgery
91d
Cleared
Jul 26, 2006
INSORB ABSORBABLE STAPLE, MODEL 1020
GDW
Staple, Implantable
30d
Cleared
Jul 26, 2006
FSSB NYLON SURGICAL SUTURES
GAR
Suture, Nonabsorbable, Synthetic, Polyamide
153d
Cleared
Jul 26, 2006
TRULENE MESH
FTL
Mesh, Surgical, Polymeric
203d
Cleared
Jul 25, 2006
HYDROMARK BIOPSY SITE MARKER
NEU
Marker, Radiographic, Implantable
125d
Cleared
Jul 20, 2006
DEL SOL BLUE LIGHT THERAPY SYSTEM
GEX
Powered Laser Surgical Instrument
55d
Cleared
Jul 19, 2006
HIGHLAND BEAM DELIVERY SYSTEM, MODEL 3-099-002-00-00
GEX
Powered Laser Surgical Instrument
13d
Cleared
Jul 19, 2006
QUIKCLOT 1ST RESPONSE & QUIKCLOT ACS+
QSY
Hemostatic Wound Dressing Without Thrombin Or Other Biologics
26d
Cleared
Jul 19, 2006
OASIS WOUND MATRIX
KGN
Wound Dressing With Animal-derived Material(s)
30d
Cleared
Jul 19, 2006
OPTILENE MESH
FTL
Mesh, Surgical, Polymeric
33d
Cleared
Jul 19, 2006
TROKAMED GMBH ENDOSCOPES AND ACCESSORIES
GCJ
Laparoscope, General & Plastic Surgery
170d
Cleared
Jul 18, 2006
SANARUS VISICA TREATMENT SYSTEM
GEH
Unit, Cryosurgical, Accessories
47d
Cleared
Jul 18, 2006
BOVIE INAFLASH SUTURE REMOVER HANDLE,CHARGER,HANDLE AND CHARGER,KIT,BATTERY PACK
GEI
Electrosurgical, Cutting & Coagulation & Accessories
69d
Cleared
Jul 18, 2006
COMPOUND W FREEZE OFF WART REMOVAL SYSTEM
GEH
Unit, Cryosurgical, Accessories
112d
Cleared
Jul 17, 2006
SURGICAL MESH SYSTEM
FTL
Mesh, Surgical, Polymeric
242d
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