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FDA 510(k)

MADDEN SURGICAL THIMBLE

K-Number: K940907 · 1994-12-29

ApplicantKelley-Gilmer Medical Corp.
Decision Date1994-12-29
Product CodeKNA
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MADDEN SURGICAL THIMBLE is the device name listed in this FDA 510(k) record. The listed applicant is Kelley-Gilmer Medical Corp.. It received FDA 510(k) clearance on 1994-12-29 under 510(k) number K940907. The device is classified under product code KNA. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MADDEN SURGICAL THIMBLE?

MADDEN SURGICAL THIMBLE is a medical device that received FDA 510(k) clearance on 1994-12-29. The listed applicant is Kelley-Gilmer Medical Corp.. The 510(k) number is K940907.

When did MADDEN SURGICAL THIMBLE receive FDA 510(k) clearance?

MADDEN SURGICAL THIMBLE received FDA 510(k) clearance on 1994-12-29, under 510(k) number K940907.

Who is the listed applicant for MADDEN SURGICAL THIMBLE?

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

What is the FDA product code for MADDEN SURGICAL THIMBLE?

The FDA product code for MADDEN SURGICAL THIMBLE is KNA.

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Related Devices (Code: KNA)

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

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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