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FDA 510(k)

CAP-STIK

K-Number: K934435 · 1995-07-14

ApplicantMcshane Medical, Inc.
Decision Date1995-07-14
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CAP-STIK is the device name listed in this FDA 510(k) record. The listed applicant is Mcshane Medical, Inc.. It received FDA 510(k) clearance on 1995-07-14 under 510(k) number K934435. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAP-STIK?

CAP-STIK is a medical device that received FDA 510(k) clearance on 1995-07-14. The listed applicant is Mcshane Medical, Inc.. The 510(k) number is K934435.

When did CAP-STIK receive FDA 510(k) clearance?

CAP-STIK received FDA 510(k) clearance on 1995-07-14, under 510(k) number K934435.

Who is the listed applicant for CAP-STIK?

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

What is the FDA product code for CAP-STIK?

The FDA product code for CAP-STIK is FMI.

Related Devices (Code: FMI)

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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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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