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FDA 510(k)

OSTOMATE THIRD HAND

K-Number: K802424 · 1980-10-31

ApplicantSmith'S Ostomy Products, Inc.
Decision Date1980-10-31
Product CodeEXB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

OSTOMATE THIRD HAND is the device name listed in this FDA 510(k) record. The listed applicant is Smith'S Ostomy Products, Inc.. It received FDA 510(k) clearance on 1980-10-31 under 510(k) number K802424. 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 OSTOMATE THIRD HAND?

OSTOMATE THIRD HAND is a medical device that received FDA 510(k) clearance on 1980-10-31. The listed applicant is Smith'S Ostomy Products, Inc.. The 510(k) number is K802424.

When did OSTOMATE THIRD HAND receive FDA 510(k) clearance?

OSTOMATE THIRD HAND received FDA 510(k) clearance on 1980-10-31, under 510(k) number K802424.

Who is the listed applicant for OSTOMATE THIRD HAND?

The FDA 510(k) record lists Smith'S Ostomy Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OSTOMATE THIRD HAND?

The FDA product code for OSTOMATE THIRD HAND is EXB.

Related Clinical Trials

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.

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Other records listing Smith'S Ostomy Products, 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.

K820493DEEP CONVEX FACE PLATE

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

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

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