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
18201
Total
18157
Cleared
138d
Avg (2y)
1976
Since
4045 General & Plastic Surgery devices
Cleared
Sep 10, 2020
SubNovii Advanced Plasma Technology
GEI
Electrosurgical, Cutting & Coagulation & Accessories
77d
Cleared
Sep 10, 2020
Diode Laser Body Sculpture System
PKT
Laser For Disruption Of Adipocyte Cells For Aesthetic Use
78d
Cleared
Sep 09, 2020
MINT Product Family
NEW
Suture, Surgical, Absorbable, Polydioxanone
371d
Cleared
Sep 04, 2020
Arthrex NanoScope System
GCJ
Laparoscope, General & Plastic Surgery
129d
Cleared
Sep 04, 2020
3M Tegaderm CHG Chlorhexidine Gluconate Gel Pad
FRO
Dressing, Wound, Drug
157d
Cleared
Sep 04, 2020
MEBO Wound Dressing
FRO
Dressing, Wound, Drug
268d
Cleared
Sep 03, 2020
Cliq Aspirator
BTA
Pump, Portable, Aspiration (manual Or Powered)
122d
Cleared
Sep 03, 2020
HaloGUARD Protective Disc with CHG
FRO
Dressing, Wound, Drug
176d
Cleared
Sep 03, 2020
Lyograft
FTM
Mesh, Surgical
360d
Cleared
Sep 02, 2020
Aesculap PAS-Port Proximal Anastomosis System
FZP
Clip, Implantable
33d
Cleared
Sep 02, 2020
ApolloVue S100 Image System
NQQ
System, Imaging, Optical Coherence Tomography (oct)
84d
Cleared
Sep 01, 2020
CAPOGEN Laser Cap
OAP
Laser, Comb, Hair
57d
Cleared
Aug 29, 2020
Masimo O3 Regional Oximeter System
MUD
Oximeter, Tissue Saturation
89d
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
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