Skip to content

Amsino Urinary Drainage Bag

by Amsino Intl., Inc.

510(k) K964745

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 NumberK964745 Date18 Mar 1997ClearedStatusActive

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  • Withdrawn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
KNX
Device Class
Class II
Regulation
21 CFR Part 876.5250
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.

A collector, urine, (and accessories) for indwelling catheter is a device intended to collect urine from sheaths or catheters. It is designed with needle-free sampling ports and anti-reflux devices to improve safety and infection prevention.

The device is supplied sterile and safe, includes an anti-reflux device, pre-pierced sampling port, T-Tap drain, and single hook with rope hanger. It is intended for use in clinical settings to collect urine from indwelling catheters or sheaths. Authorization is based on FDA 510(k) clearance under K964745, with product code KNX and regulation number 876.5250.

Other devices from Amsino Intl., Inc.

See all devices from Amsino Intl., 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 AMSINO URINARY DRAINAGE BAG used for?

    The AMSINO URINARY DRAINAGE BAG is intended to collect urine from sheaths or indwelling catheters in clinical settings, featuring needle-free sampling ports and anti-reflux devices to enhance safety and reduce infection risk during urine collection.

  • How is the AMSINO URINARY DRAINAGE BAG supplied and is it sterile?

    The device is supplied sterile and includes an anti-reflux device, pre-pierced sampling port, T-Tap drain, and a single hook with rope hanger, ensuring it is ready for immediate use in clinical environments without additional sterilization.

  • What regulatory pathway was used for the AMSINO URINARY DRAINAGE BAG?

    The AMSINO URINARY DRAINAGE BAG received market authorization through FDA 510(k) clearance under submission K964745, demonstrating substantial equivalence to a legally marketed predicate device under product code KNX and regulation 876.5250.