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
Apr 14, 2005
THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTAT
QSX
Hemostatic Wound Dressing With Thrombin Or Other Biologics
44d
Cleared
Apr 14, 2005
OCULIGHT GL/GLX
GEX
Powered Laser Surgical Instrument
42d
Cleared
Apr 14, 2005
QUIKCLOT BRAND HEMOSTATIC AGENT - ADVANCED BEADED FORMULATION - 100G - 1.9MM - 2.4MM., MODEL 100172
QSY
Hemostatic Wound Dressing Without Thrombin Or Other Biologics
20d
Cleared
Apr 12, 2005
REPROCESSED HARMONIC SCALPELS
NLQ
Single-use Reprocessed Ultrasonic Surgical Instruments
60d
Cleared
Apr 12, 2005
AURORA DS, DS APPLICATOR
GEX
Powered Laser Surgical Instrument
14d
Cleared
Apr 12, 2005
STELLARTECH COAGULATION SYSTEM 2, MODELS 1100C-115A AND 1100C-230A
GEI
Electrosurgical, Cutting & Coagulation & Accessories
11d
Cleared
Apr 08, 2005
TRUGLYDE ABSORBABLE POLYGLYCOLIC ACID SURGICAL SUTURE
GAM
Suture, Absorbable, Synthetic, Polyglycolic Acid
305d
Cleared
Apr 08, 2005
LUPINE LOOP
GAM
Suture, Absorbable, Synthetic, Polyglycolic Acid
14d
Cleared
Apr 07, 2005
SURGITRON RADIOLASE II
GEI
Electrosurgical, Cutting & Coagulation & Accessories
189d
Cleared
Apr 06, 2005
DEMETECH STERILE SYNTHETIC ABSORBABLE SUTURES (PGA) AND NEEDLES
GAM
Suture, Absorbable, Synthetic, Polyglycolic Acid
105d
Cleared
Apr 06, 2005
ENDOTINE RIBBON
GAM
Suture, Absorbable, Synthetic, Polyglycolic Acid
28d
Cleared
Apr 01, 2005
CONTOUR MIDFACE OPPOSING UNI-DIRECTIONAL THREADS
GAW
Suture, Nonabsorbable, Synthetic, Polypropylene
30d
Cleared
Apr 01, 2005
ENSEAL VESSEL SEALING & HEMOSTASIS SYSTEM
GEI
Electrosurgical, Cutting & Coagulation & Accessories
17d
Cleared
Mar 31, 2005
GRAFTSAVER
GBX
Catheter, Irrigation
101d
Cleared
Mar 31, 2005
CUTERA OPTIONAL PULSED LIGHT HAND PIECE FAMILY
GEX
Powered Laser Surgical Instrument
80d
Cleared
Mar 31, 2005
CUTERA SOLERA OPUS AESTHETIC PRODUCT
GEX
Powered Laser Surgical Instrument
15d
Cleared
Mar 31, 2005
NEOTHERMIA EN-BLOC BIOPSY SYSTEM
GEI
Electrosurgical, Cutting & Coagulation & Accessories
10d
Cleared
Mar 24, 2005
OXYBAND WOUND DRESSING
NAD
Dressing, Wound, Occlusive
139d
Cleared
Mar 24, 2005
BIOSYAG 50 MED
GEX
Powered Laser Surgical Instrument
94d
Cleared
Mar 24, 2005
HENKE SASS WOLF OF AMERICA BARIATRIC LAPAROSCOPE
GCJ
Laparoscope, General & Plastic Surgery
58d
Cleared
Mar 24, 2005
AOC BONE WAX, OSTENE, OSTEOTENE, ORTHOSEAL, OSTEOSEAL, CERETENE, MODEL BW-12
MTJ
Wax, Bone
30d
Cleared
Mar 24, 2005
MEGA POWER ELECTROSURGICAL GENERATOR
GEI
Electrosurgical, Cutting & Coagulation & Accessories
17d
Cleared
Mar 22, 2005
VANGUARD REPROCESSED ULTRASONIC SCALPEL
NLQ
Single-use Reprocessed Ultrasonic Surgical Instruments
120d
Cleared
Mar 22, 2005
VANGUARD REPROCESSED HAND-ACTIVATED ULTRASONIC SCALPEL
NLQ
Single-use Reprocessed Ultrasonic Surgical Instruments
111d
Cleared
Mar 18, 2005
OMNILUX REVIVE AND BLUE
GEX
Powered Laser Surgical Instrument
106d
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