Gem FlowCoupler System— 510(k) K191252
Substantially EquivalentBaxter/ Synovis Micro Companies Alliance, Inc.
FDA 510(k) clearance K191252 for Gem FlowCoupler System, Substantially Equivalent on 2019-07-09. Applicant: Baxter/ Synovis Micro Companies Alliance, Inc.. Device class: 2.
Clearance details
- Applicant
- Baxter/ Synovis Micro Companies Alliance, Inc.
- Product code
- Code MVR
- Device class
- Class 2
- Regulation
- 21 CFR 878.4300
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St. Paul, MN, US
Recent devices under product code MVR
view allRecalls naming K191252
K-number listed on FDA's recall record- Z-2208-2023 — GEM FLOW COUPLER Monitor, PN 5156-00000-011
- Z-0939-2021 — FLOW COUPLER Monitor Flow Coupler devices are sold in 5 sizes (2.0 mm, 2.5 mm, 3.0 mm, 3.5 mm, 4.0 mm). Implantable device for vascular use.
- Z-2474-2020 — Flow Coupler Monitor, GEM, Global Excellence Microsurgery, Rx Only
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K191252.
Data sourced from openFDA. This site is unofficial and independent of the FDA.