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Flo-Rester

by Bio-Vascular, Inc.

510(k) K883696

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK883696 Date30 Nov 1988ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0656-2024 FDA Class II initiated 6 Dec 2023

    Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DXC
Device Class
Class II
Regulation
21 CFR Part 870.4450
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Flo-Rester Vessel Sizer is a medical device classified under product code DXC, designed for measuring the internal diameter of blood vessels. It is intended to assist in vascular procedures by providing precise sizing information, which helps in selecting appropriate surgical tools or grafts for anastomosis. This aids surgeons in maintaining proper blood flow and vessel patency during procedures such as bypass surgeries or vascular repairs.

The Flo-Rester Vessel Sizer is a single-use, non-sterile device supplied in a sterile package for clinical use. It is intended for use in operating rooms and vascular labs, where accurate vessel sizing is critical. The device received FDA 510(k) clearance under K883696 and is regulated under the Traditional 510(k) review pathway. No additional regulatory approvals beyond the stated clearance are referenced in the available data.

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