510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K191252Substantially Equivalent

Gem FlowCoupler System

Baxter/ Synovis Micro Companies Alliance, Inc., St. Paul MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K191252 is the FDA 510(k) clearance record for Gem FlowCoupler System, a class II device, cleared for Baxter/ Synovis Micro Companies Alliance, Inc. on under FDA product code MVR (Device, Anastomotic, Microvascular). FDA records list 2 510(k) clearances for Baxter/ Synovis Micro Companies Alliance, Inc., from to . As of , FDA records show 3 recalls naming K191252.

Clearance record

Decision date
Received
(61 days to decision)
Product code
MVR Device, Anastomotic, Microvascular
Regulation
21 CFR 878.4300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Baxter/ Synovis Micro Companies Alliance, Inc. 2875 University Ave. W., St. Paul MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MVR

Trailing 12 months

FDA records hold no clearances under product code MVR in the trailing twelve months.

FDA records show no clearances under product code MVR in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MVR, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260