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
13563 General & Plastic Surgery devices
Cleared
Aug 28, 2020
OrthoGold 100
PZL
Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers
143d
Cleared
Aug 28, 2020
Hemostatic Xerogel Sponge
QSY
Hemostatic Wound Dressing Without Thrombin Or Other Biologics
337d
Cleared
Aug 27, 2020
APTOS Threads – Polypropylene Surgical Sutures
GAW
Suture, Nonabsorbable, Synthetic, Polypropylene
311d
Cleared
Aug 26, 2020
VersaOne Reusable Positioning Trocar System
GCJ
Laparoscope, General & Plastic Surgery
56d
Cleared
Aug 26, 2020
Emprint Ablation System with Thermosphere Technology
NEY
System, Ablation, Microwave And Accessories
153d
Cleared
Aug 21, 2020
BTL-785F
GEI
Electrosurgical, Cutting & Coagulation & Accessories
275d
Cleared
Aug 20, 2020
FUJIFILM Video Laparoscope
GCJ
Laparoscope, General & Plastic Surgery
20d
Cleared
Aug 19, 2020
Medline ReNewal Reprocessed Harmonic ACE+7 Shears
NLQ
Single-use Reprocessed Ultrasonic Surgical Instruments
240d
Cleared
Aug 19, 2020
invisa-RED ELITE
OLI
Fat Reducing Low Level Laser
363d
Cleared
Aug 18, 2020
Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System
KNW
Instrument, Biopsy
28d
Cleared
Aug 17, 2020
HOPKINS ICG/NIR 10mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 5mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 4mm Ridgid Endoscope 0°, 30°, 45°, VITOM II ICG/NIR Telescope, Power LED Rubina Light Source, Foot Switch, Fiber Optic Light Cable, Image S CCU, Image S 4U Rubina Camera Head
OWN
Confocal Optical Imaging
81d
Cleared
Aug 12, 2020
Aurora Evacuator +Coag
GEI
Electrosurgical, Cutting & Coagulation & Accessories
57d
Cleared
Aug 12, 2020
SNA-001 Silver Photoparticle Topical Gel
QCY
Laser Absorbing Particles
324d
Cleared
Aug 11, 2020
CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe, Short, Round Ice
GEH
Unit, Cryosurgical, Accessories
60d
Cleared
Aug 11, 2020
NuEra Tight, NuEra Tight EMS
PBX
Massager, Vacuum, Radio Frequency Induced Heat
180d
Cleared
Aug 06, 2020
Disposable Laparoscope Trocar
GCJ
Laparoscope, General & Plastic Surgery
51d
Cleared
Aug 06, 2020
VICRYL Mesh
FTL
Mesh, Surgical, Polymeric
99d
Cleared
Aug 03, 2020
Electrodes Handpieces for Mygen V-1000 RF System
GEI
Electrosurgical, Cutting & Coagulation & Accessories
243d
Cleared
Jul 31, 2020
BiPad Hand Activated, Disposable Bipolar Electrocautery Cords
GEI
Electrosurgical, Cutting & Coagulation & Accessories
29d
Cleared
Jul 31, 2020
Reprocessed Endoscopic Trocars and Sleeves
NLM
Laparoscope, General & Plastic Surgery, Reprocessed
56d
Cleared
Jul 31, 2020
Kendall NPWT Incision Management Dressing Kit
OMP
Negative Pressure Wound Therapy Powered Suction Pump
463d
Cleared
Jul 29, 2020
Symphony
KGN
Wound Dressing With Animal-derived Material(s)
161d
Cleared
Jul 28, 2020
Connected OR Hub with Voice Control, Connected OR Hub with Device Control
GCJ
Laparoscope, General & Plastic Surgery
57d
Cleared
Jul 27, 2020
Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed
GDW
Staple, Implantable
75d
Cleared
Jul 24, 2020
Single Use Electrosurgical Knife
GEI
Electrosurgical, Cutting & Coagulation & Accessories
214d
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