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FDA 510(k)

NORTA (TM) UROBAG

K-Number: K870504 · 1987-04-01

ApplicantBeiersdorf, Inc.
Decision Date1987-04-01
Product CodeKNX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NORTA (TM) UROBAG is the device name listed in this FDA 510(k) record. The listed applicant is Beiersdorf, Inc.. It received FDA 510(k) clearance on 1987-04-01 under 510(k) number K870504. The device is classified under product code KNX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NORTA (TM) UROBAG?

NORTA (TM) UROBAG is a medical device that received FDA 510(k) clearance on 1987-04-01. The listed applicant is Beiersdorf, Inc.. The 510(k) number is K870504.

When did NORTA (TM) UROBAG receive FDA 510(k) clearance?

NORTA (TM) UROBAG received FDA 510(k) clearance on 1987-04-01, under 510(k) number K870504.

Who is the listed applicant for NORTA (TM) UROBAG?

The FDA 510(k) record lists Beiersdorf, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NORTA (TM) UROBAG?

The FDA product code for NORTA (TM) UROBAG is KNX.

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Other records listing Beiersdorf, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K090921ANTI-EMBOLISM STOCKINGS, MODELS 71055-00000-02, 71057-00000-02, 71059-00000-02, 71064-00000-02 & 71065-00000-02K024057CURAD SCAR THERAPYK952526CUTINOVA CAVITYK943363CUTIPLAST STERILK944581CUTINOVA THIN WOUND DRESSINGK935630NORTA

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Related Devices (Code: KNX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K110518IBAGFuture Path Medical, LLCK9733644L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAGMaersk Medical A/SK972887MEDLINE PREMIUM LEG BAG, MEDLINE FABRIC BAC LEG BAG, MEDLINE URINARY LEG BAGMedline Industries, Inc.K971271BESECURE EXTERNAL URINARY COLLECTION SYSTEMUrology Research Intl., Inc.K971929AMSINO URINARY LEG BAGAmsino Intl., Inc.K971764WELCON HUE-VU URINARY DRAINAGE BAGWelcon, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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