Navarre 600 ML Drainage Bag

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

510(k) Number

K943663 ↗

FDA Product Code

EXF

FDA applicant

Navarre Biomedical , Ltd.

Device Class

Class II

Regulation

21 CFR Part 876.5010

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Navarre Locking Pigtail Universal Drainage Catheter

  Class I

  FDA 510(k) K951907 Active Cleared 15 May 1995

• Navarre Biomedical Tip-Locking Drainage Catheters

  Class I

  FDA 510(k) K933600 Active Cleared 28 Mar 1994

• Navarre Percutaneous Access Set

  Class I

  FDA 510(k) K942315 Active Cleared 8 Jul 1994

• Opti-Drain Multi-Use Drainage Catheter

  Class I

  FDA 510(k) K955505 Active Cleared 7 Feb 1996

• Navarre Biomedical Universal Drainage Catheter Set

  Class I

  FDA 510(k) K932391 Active Cleared 27 Jan 1994

• Navarre Percutaneous Biliary Drainage

  Class II

  FDA 510(k) K955110 Active Cleared 7 Nov 1996

See all devices from Navarre Biomedical, Ltd. →

• What is the Navarre 600 ML Drainage Bag used for?

  The Navarre 600 ML Drainage Bag is designed for the collection of bile or other bodily fluids in clinical settings, specifically in gastroenterology and urology applications as indicated in its device classification and intended use.

• Is the Navarre 600 ML Drainage Bag sterile or non-sterile, and is it intended for single-use or reuse?

  The device is supplied non-sterile and is intended for single-use only, as explicitly stated in the device description, meaning it should not be reprocessed or reused after initial use.

• What regulatory authorization does the Navarre 600 ML Drainage Bag have?

  The Navarre 600 ML Drainage Bag is authorized under FDA 510(k) clearance K943663, which determined it to be substantially equivalent to a legally marketed predicate device, and it is classified as a Class II medical device under regulation 876.5010.