Skip to content

Dynacor Sterile Closed Sys. Drainage Bag

by Medline Industries, Inc.

510(k) K791969

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 NumberK791969 Date5 Nov 1979ClearedStatusActive

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  • Withdrawn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, 19 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 Dynacor Sterile Closed System Drainage Bag is a Collector, Urine, (And Accessories) For Indwelling Catheter, designed to safely collect and contain urine drainage from indwelling catheters in a sterile, closed system. Its closed design prevents contamination and backflow, reducing the risk of urinary tract infections while maintaining patient hygiene.

This single-use, sterile device is intended for use in clinical settings such as hospitals, urology, and gastroenterology procedures. Supplied in a sterile package, it adheres to FDA 510(k) clearance (K791969) under regulation 876.5250 and is classified as a Class II medical device. Proper storage and handling ensure sterility and functionality before use.

Other devices from Medline Industries, Inc.

See all devices from Medline Industries, Inc. →