FDA 510(k)

OSTO-PURE

K-Number: K871738 · 1987-08-12

Decision Date1987-08-12

Product CodeEXB

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

OSTO-PURE is the device name listed in this FDA 510(k) record. The listed applicant is Clearchem Corp.. It received FDA 510(k) clearance on 1987-08-12 under 510(k) number K871738. 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 OSTO-PURE?

OSTO-PURE is a medical device that received FDA 510(k) clearance on 1987-08-12. The listed applicant is Clearchem Corp.. The 510(k) number is K871738.

When did OSTO-PURE receive FDA 510(k) clearance?

OSTO-PURE received FDA 510(k) clearance on 1987-08-12, under 510(k) number K871738.

Who is the listed applicant for OSTO-PURE?

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

What is the FDA product code for OSTO-PURE?

The FDA product code for OSTO-PURE is EXB.

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 Limited K922730LAKE OSTOMY CARE SETLake Medical Products, Inc.K882878ODOR-END EMERGENCY CLEAN UP POWDERCdc Products Corp.K881636CONSEAL COLOSTOMY CONTINENCE SYSTEM (ONE-PIECE)Coloplast A/S K880306EMERGENCY-CLEAN UP(TM) ECPCdc Products Corp.

Official Source

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