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FDA 510(k)

COLOPLAST CONVEX RING

K-Number: K861070 · 1986-06-16

ApplicantColoplast A/S
Decision Date1986-06-16
Product CodeEXB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

COLOPLAST CONVEX RING 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 1986-06-16 under 510(k) number K861070. 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 CONVEX RING?

COLOPLAST CONVEX RING is a medical device that received FDA 510(k) clearance on 1986-06-16. The listed applicant is Coloplast A/S. The 510(k) number is K861070.

When did COLOPLAST CONVEX RING receive FDA 510(k) clearance?

COLOPLAST CONVEX RING received FDA 510(k) clearance on 1986-06-16, under 510(k) number K861070.

Who is the listed applicant for COLOPLAST CONVEX RING?

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 CONVEX RING?

The FDA product code for COLOPLAST CONVEX RING 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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