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
13834 General & Plastic Surgery devices
Cleared
Jun 10, 2009
TRIOS SYSTEM
ONF
Powered Light Based Non-laser Surgical Instrument With Thermal Effect
113d
Cleared
Jun 05, 2009
PEAK PLASMABLADE TNA TONSIL AND ADENOID TISSUE DISSECTION DEVICE
GEI
Electrosurgical, Cutting & Coagulation & Accessories
199d
Cleared
Jun 04, 2009
MODIFIED INTERMEDIC DIODE LASER 980NM SYSTEM (MULTIDIODE SST 200)
GEX
Powered Laser Surgical Instrument
30d
Cleared
Jun 04, 2009
C-QUR V -PATCH MESH
FTL
Mesh, Surgical, Polymeric
64d
Cleared
Jun 02, 2009
PFR SLING SYSTEM, PART OF THE AMS PELVIC FLOOR REPAIR SYSTEM
FTL
Mesh, Surgical, Polymeric
61d
Cleared
Jun 02, 2009
MEGAPULSE LASER SYSTEM AND FIBERS
GEX
Powered Laser Surgical Instrument
71d
Cleared
Jun 02, 2009
NOBEL BIOCARE ENDOSSEOUS IMPLANTS (MAXILLOFACIAL INDICATION)
FZE
Prosthesis, Nose, Internal
85d
Cleared
Jun 02, 2009
OCULUS PURACYN ANTIMICROBIAL SKIN AND WOUND CLEANSER
FRO
Dressing, Wound, Drug
125d
Cleared
Jun 01, 2009
CONTOUR CURVED CUTTER STAPLER AND RELOADS, MODELS: CS40B, CS40G, CR40B, CR40G
GDW
Staple, Implantable
27d
Cleared
Jun 01, 2009
LOI SYSTEM
ONG
Powered Laser Surgical Instrument With Microbeamfractional Output
95d
Cleared
Jun 01, 2009
REVLITE Q-SWITCHED ND:YAG LASER SYSTEM
GEX
Powered Laser Surgical Instrument
154d
Cleared
May 29, 2009
TANTHERA-T35
LEJ
Booth, Sun Tan
64d
Cleared
May 28, 2009
DISPOSABLE HANDLE ASSEMBLES, MODELS DH0100 AND DH0500 SERIES
GCJ
Laparoscope, General & Plastic Surgery
51d
Cleared
May 27, 2009
XYLOS POROUS SURGICAL MESH
FTM
Mesh, Surgical
57d
Cleared
May 22, 2009
FREEHAND
GCJ
Laparoscope, General & Plastic Surgery
101d
Cleared
May 20, 2009
APLION TOPICAL CARE SYSTEM
NAD
Dressing, Wound, Occlusive
30d
Cleared
May 20, 2009
OCULUS MICROCYN WOUND GEL
FRO
Dressing, Wound, Drug
62d
Cleared
May 20, 2009
SUPRATHEL WOUND AND BURN DRESSING
QSZ
Absorbable Synthetic Wound Dressing
118d
Cleared
May 20, 2009
ZELTIQ SYSTEM
GEX
Powered Laser Surgical Instrument
126d
Cleared
May 18, 2009
INTELLIGENT POWER UNIT, INTELLIGENT CONSOLE, INTELLIGENT DELIVERY SYSTEM, INTELLIGENT SURGICAL INSTRUMENT
GDW
Staple, Implantable
21d
Cleared
May 18, 2009
ALGISEAL PAD
QSY
Hemostatic Wound Dressing Without Thrombin Or Other Biologics
25d
Cleared
May 18, 2009
LIPOKIT WITH DISPOSABLE 50CC AFT SYRINGE, MODEL ZLK-100
MUU
System, Suction, Lipoplasty
178d
Cleared
May 15, 2009
LOTUS II PULSED ER: YAG LASER SYSTEM
GEX
Powered Laser Surgical Instrument
192d
Cleared
May 14, 2009
ABTHERA OPEN ABDOMEN DRESSING, MODEL: M8275026
FTL
Mesh, Surgical, Polymeric
78d
Cleared
May 14, 2009
AUTOSUTURE PROTACK
OCW
Endoscopic Tissue Approximation Device
80d
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