REPROCESSED CLOSUREFAST RADIOFREQUENCY CATHETER 60CM, REPROCESSED CLOSUREFAST RADIOFREQUENCY CATHETER 100CM— 510(k) K131614

Name: FDA 510(k) clearance K131614
Creator: U.S. Food and Drug Administration
Published: 2013-08-29

Substantially Equivalent

Covidien

FDA 510(k) clearance K131614 for REPROCESSED CLOSUREFAST RADIOFREQUENCY CATHETER 60CM, REPROCESSED CLOSUREFAST RADIOFREQUENCY CATHETER 100CM, Substantially Equivalent on 2013-08-29. Applicant: Covidien. Device class: 2.

Clearance details

Applicant: Covidien
Product code: Code NUJ
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 2013-06-03
Decision date: 2013-08-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mansfield, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NUJ

view all

K232511 — Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019)2024-04-29
K230251 — Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)2023-03-28
K220411 — Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)2022-05-13
K211203 — Green OR Reprocessed Aquamantys Bipolar Sealer2022-04-07
K191073 — Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter2019-10-22

More clearances from Covidien

view all

K241486 — Sofsilk Coated Braided Silk Suture2024-12-03
K240077 — Mon-a-Therm General Purpose Temperature Probe 400TM (90050, 90044)2024-08-20
K231934 — GIA Stapler with Tri-Staple Technology2023-10-27
K231240 — MaxTack Motorized Fixation Device2023-09-08
K223130 — Shiley Pediatric Oral/Nasal Endotracheal Tube with TaperGuard Cuff, Non DEHP (86125, 86130, 86135, 86140, 86145, 86150, 86155, 86160)2023-08-30

Data sourced from openFDA. This site is unofficial and independent of the FDA.