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
13786 General & Plastic Surgery devices
Cleared
Jul 25, 2012
IDRIVE ULTRA POWERED HANDLE ENDO GIA ADAPTER
GDW
Staple, Implantable
65d
Cleared
Jul 25, 2012
AQUACEL AG EXTRA HYDROFIBER DRESSING WITH SILVER AND STRENGTHENING FIBER
FRO
Dressing, Wound, Drug
89d
Cleared
Jul 25, 2012
NVISION VLE IMAGING SYSTEM NVISION VLE CATHETER
NQQ
System, Imaging, Optical Coherence Tomography (oct)
97d
Cleared
Jul 25, 2012
TL TRISEB CREAM
FRO
Dressing, Wound, Drug
103d
Cleared
Jul 25, 2012
POSISEP AND POSISEP X HEMOSTAT DRESSINGS
QSY
Hemostatic Wound Dressing Without Thrombin Or Other Biologics
117d
Cleared
Jul 25, 2012
ADVERL EVO ER: YAG LASER FOR DENTISTRY MEY-1-A
GEX
Powered Laser Surgical Instrument
170d
Cleared
Jul 20, 2012
VENTRIO LIGHT HERNIA PATCH WITH TRM ANTIMICROBIAL COATING
FTL
Mesh, Surgical, Polymeric
261d
Cleared
Jul 18, 2012
POLARIS Q-SWITCH RUBY SYSTEM
GEX
Powered Laser Surgical Instrument
92d
Cleared
Jul 17, 2012
TIO2MESH TM
FTL
Mesh, Surgical, Polymeric
251d
Cleared
Jul 16, 2012
ECHELON 60 ENDOSCPIC LINEAR CUTTER RELOAD, WHITE
GDW
Staple, Implantable
45d
Cleared
Jul 16, 2012
DISPOSABLE LINEAR STAPLER, DISPOSABLE LINEAR CUTTER
GDW
Staple, Implantable
59d
Cleared
Jul 13, 2012
QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIXANONE)
NEW
Suture, Surgical, Absorbable, Polydioxanone
116d
Cleared
Jul 13, 2012
PLANCET
FMK
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
228d
Cleared
Jul 12, 2012
SMARTSTITCH M-CONNECTOR ULTRA SMARTSTITCH SUTURE DEVICE HANDLE SMARTSTITCH SUTURE DEVICE HANDLE
GAT
Suture, Nonabsorbable, Synthetic, Polyethylene
72d
Cleared
Jul 12, 2012
BIOPSY SCIENCES, INC. HYDROMARK BREST BIOSY SITE MARKER
NEU
Marker, Radiographic, Implantable
91d
Cleared
Jul 10, 2012
LIGHTSCALPEL FAMILY OF HANDPIECE TIPS FOR CO2 SURGICAL LASERS
GEX
Powered Laser Surgical Instrument
53d
Cleared
Jul 10, 2012
AYNERGETICS DISPOSABLE SPETZLER-MALIS STANDARD BIPOLAR FORCEPS
GEI
Electrosurgical, Cutting & Coagulation & Accessories
57d
Cleared
Jul 09, 2012
OXYBAND WOUND DRESSING
FRO
Dressing, Wound, Drug
60d
Cleared
Jul 06, 2012
NCIRCLE(R) NITINOL TIPLESS STONE EXTRACTOR NGAGE(R) NITINOL STONE EXTRACTOR
GCJ
Laparoscope, General & Plastic Surgery
141d
Cleared
Jul 05, 2012
ILUMINAGE DIODE LASER
OHS
Light Based Over The Counter Wrinkle Reduction
407d
Cleared
Jul 03, 2012
NATROX TOPICAL OXYGEN DELIVERY SYSTEM WITH IODP
KPJ
Chamber, Oxygen, Topical, Extremity
298d
Cleared
Jun 29, 2012
SYSTEMS INTEGRATION
GCJ
Laparoscope, General & Plastic Surgery
21d
Cleared
Jun 29, 2012
PROGRIP LAPARSCOPIC SELF-FIXATING MESH
FTL
Mesh, Surgical, Polymeric
95d
Cleared
Jun 29, 2012
SC TIP CLEANER
GEI
Electrosurgical, Cutting & Coagulation & Accessories
123d
Cleared
Jun 29, 2012
AC WOUND TREATMENT SYSTEM
OMP
Negative Pressure Wound Therapy Powered Suction Pump
357d
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