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FDA 510(k)

COLOPLAST URO 2002 UROSTOMY SYSTEM

K-Number: K844685 · 1985-01-08

ApplicantColoplast A/S
Decision Date1985-01-08
Product CodeEXB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

COLOPLAST URO 2002 UROSTOMY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast A/S. It received FDA 510(k) clearance on 1985-01-08 under 510(k) number K844685. The device is classified under product code EXB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COLOPLAST URO 2002 UROSTOMY SYSTEM?

COLOPLAST URO 2002 UROSTOMY SYSTEM is a medical device that received FDA 510(k) clearance on 1985-01-08. The listed applicant is Coloplast A/S. The 510(k) number is K844685.

When did COLOPLAST URO 2002 UROSTOMY SYSTEM receive FDA 510(k) clearance?

COLOPLAST URO 2002 UROSTOMY SYSTEM received FDA 510(k) clearance on 1985-01-08, under 510(k) number K844685.

Who is the listed applicant for COLOPLAST URO 2002 UROSTOMY SYSTEM?

The FDA 510(k) record lists Coloplast A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COLOPLAST URO 2002 UROSTOMY SYSTEM?

The FDA product code for COLOPLAST URO 2002 UROSTOMY SYSTEM is EXB.

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Other records listing Coloplast A/S as applicant

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Related Devices (Code: EXB)

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.

K252140Heylo™ SystemColoplast Corp.K181643SmartBag (SmartPouch)11 Health Technologies LimitedK922730LAKE OSTOMY CARE SETLake Medical Products, Inc.K882878ODOR-END EMERGENCY CLEAN UP POWDERCdc Products Corp.K881636CONSEAL COLOSTOMY CONTINENCE SYSTEM (ONE-PIECE)Coloplast A/SK880306EMERGENCY-CLEAN UP(TM) ECPCdc Products Corp.

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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