Cleared Special

K221843 - GEM Biover Microvascular Clamps (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K221843 · Synovis Micro Companies Alliance, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
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Sep 2022
Decision
82d
Days
Class 2
Risk

K221843 is an FDA 510(k) clearance for the GEM Biover Microvascular Clamps. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Synovis Micro Companies Alliance, Inc. (Birmingham, US). The FDA issued a Cleared decision on September 14, 2022 after a review of 82 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4450 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Synovis Micro Companies Alliance, Inc. devices

Submission Details

510(k) Number K221843 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 2022
Decision Date September 14, 2022
Days to Decision 82 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 125d · This submission: 82d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DXC Clamp, Vascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4450
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DXC Clamp, Vascular

All 201
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