Product code MVR— General, Plastic Surgery
GEM FLOW COUPLER DEVICE AND SYSTEM
- Classification name
- Device, Anastomotic, Microvascular
- Device class
- Class 2
- Regulation
- 21 CFR 878.4300
- Advisory panel
- General, Plastic Surgery
- Total cleared
- 9
- First cleared
- Most recent
Market context for product code MVR
FDA has cleared devices under product code MVR between 1986 and 2019, filed by 5 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2019
- 2015
- 2014
- 2013
- 2010
- 2009
- 2004
- 1986
Top applicants under product code MVR
Recent clearances under product code MVR
- K190499 — Gem FlowCoupler System
- K191252 — Gem FlowCoupler System
- K143589 — GEM Flow COUPLER Device and System
- K142309 — GEM Flow COUPLER Device and System
- K132727 — GEM FLOW COUPLER DEVICE AND SYSTEM
- K093310 — GEM FLOW COUPLER DEVICE AND SYSTEM
- K090679 — VESSELINK MICROVASCULAR ANASTOMOTIC COUPLER SYSTEM
- K040163 — MICROVASCULAR ANASTOMOTIC DEVICE
- K861985 — 3M BRAND MICROVASCULAR ANASTOMOTIC COUPLER (27XX)
Data sourced from openFDA. This site is unofficial and independent of the FDA.