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Bi-Phasic Infiltrator

by Reliance Medical Corp.

510(k) K012044

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

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 NumberK012044 Date28 Aug 2001ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
FRN
Device Class
Class II
Regulation
21 CFR Part 880.5725
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 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 Bi-Phasic Infiltrator is a surgical device designed for fluid irrigation and infiltration, functioning by delivering fluids to a surgical site to assist in procedures. It is used in clinical settings by surgeons or trained medical staff to facilitate fluid management during surgery. The device is intended to maintain site hydration and potentially improve procedural efficiency and patient outcomes.

The Bi-Phasic Infiltrator is supplied as a single device and is regulated under the product code FRN, with a regulation number of 880.5725. It has been cleared under FDA 510(k) with the clearance type being Traditional, and the k number is K012044. The device is designed for use in general hospital settings.

Other devices from Reliance Medical Corp.

Questions

AI-generated answers, 6 Oct 2026

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

  • What is the Bi-Phasic Infiltrator used for?

    The Bi-Phasic Infiltrator is used for fluid irrigation and infiltration in surgical procedures to maintain site hydration and improve procedural efficiency and patient outcomes.

  • Is the Bi-Phasic Infiltrator supplied sterile?

    The description does not explicitly state that the Bi-Phasic Infiltrator is supplied sterile, but it is intended for use in clinical settings by surgeons or trained medical staff.

  • Is the Bi-Phasic Infiltrator a single-use device?

    The Bi-Phasic Infiltrator is supplied as a single device, but its intended use as single-use or reusable is not explicitly stated in the provided information.