GEM Flow COUPLER Device and System— 510(k) K142309

Name: FDA 510(k) clearance K142309
Creator: U.S. Food and Drug Administration
Published: 2014-09-16

Substantially Equivalent

Synovis Life Technologies, Inc.

FDA 510(k) clearance K142309 for GEM Flow COUPLER Device and System, Substantially Equivalent on 2014-09-16. Applicant: Synovis Life Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Synovis Life Technologies, Inc.
Product code: Code MVR
Device class: Class 2
Regulation: 21 CFR 878.4300
Advisory panel: General, Plastic Surgery
Date received: 2014-08-19
Decision date: 2014-09-16
Decision: Substantially Equivalent
Clearance type: Special
Location: St. Paul, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MVR

view all

K190499 — Gem FlowCoupler System2019-09-06
K191252 — Gem FlowCoupler System2019-07-09
K143589 — GEM Flow COUPLER Device and System2015-01-16
K132727 — GEM FLOW COUPLER DEVICE AND SYSTEM2013-10-22
K093310 — GEM FLOW COUPLER DEVICE AND SYSTEM2010-02-01

More clearances from Synovis Life Technologies, Inc.

view all

K223052 — Peri-Guard and Supple Peri-Guard2023-04-07
K221029 — PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch2022-10-19
K221032 — Vascu-Guard Vascular Repair Patch2022-10-19
K142447 — PERI-GUARD Repair Patch & SUPPLE PERI-GUARD Repair Patch2015-01-07
K142461 — VASCU-GUARD Peripheral Vascular Patch2014-11-25

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