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Modification To: Lofric Plus Single Use Urinary Catheter

by Astra Tech, Inc.

510(k) K012374

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 · Special NumberK012374 Date23 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  • Withdrawn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
GBM
Device Class
Class II
Regulation
21 CFR Part 876.5130
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

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

This device is a single-use urinary catheter designed for intermittent bladder drainage. It consists of a catheter coated with a hydrophilic low-friction coating that becomes slippery upon immersion in water or physiological saline solution for 30 seconds, facilitating insertion.

The device is supplied sterile and intended for single use. It is classified as a Class II medical device under FDA regulation number 876.5130 and has received FDA 510(k) clearance (K012374) as substantially equivalent to a predicate device. The product is manufactured by Astra Tech, Inc. in Northborough, MA, and is authorized for distribution in the United States.

Other devices from Astra Tech, Inc.

See all devices from Astra Tech, Inc. →

Questions

AI-generated answers, 25 Sep 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 Modification to: LoFric Plus Single Use Urinary Catheter used for?

    This device is designed for intermittent bladder drainage, allowing temporary emptying of the bladder in patients who cannot void naturally. It is intended for single use only and is not meant for indwelling or long-term catheterization.

  • How is the Modification to: LoFric Plus Single Use Urinary Catheter supplied and prepared for use?

    The catheter is supplied sterile and features a hydrophilic low-friction coating that activates upon immersion in water or physiological saline solution for 30 seconds, becoming slippery to facilitate smooth insertion during intermittent catheterization.

  • Is the Modification to: LoFric Plus Single Use Urinary Catheter reusable or single-use?

    The device is explicitly intended for single use only and must be discarded after each catheterization procedure. Reuse is not recommended as it may compromise sterility, coating integrity, and patient safety.