Skip to content

Pennine Leg Bag 350ML CAT.NO.DB3 & 500ML.CAT.#DB5

by Samco Industries, Inc.

510(k) K863671

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 NumberK863671 Date3 Oct 1986ClearedStatusActive

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  • Withdrawn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, 21 Sep 2026

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

The device is a Collector, Urine, (And Accessories) For Indwelling Catheter, as defined by the nomenclature authority. It is a leg bag designed for urine collection, available in 350ml and 500ml capacities with catalog numbers DB3 and DB5 respectively.

It is supplied as a non-sterile, single-use device intended for use in healthcare settings. The device received FDA 510(k) clearance (K863671) on October 3, 1986, and is classified as a Class II medical device under product code KNX. Storage and handling should follow manufacturer guidelines, though specific conditions are not detailed in the provided data.

Other devices from Samco Industries, Inc.