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FDA 510(k)

INFLATABLE RETENTION CUFF SPECULUM

K-Number: K941391 · 1994-10-20

ApplicantInnovatec Medical Corp.
Decision Date1994-10-20
Product CodeGBT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

INFLATABLE RETENTION CUFF SPECULUM is the device name listed in this FDA 510(k) record. The listed applicant is Innovatec Medical Corp.. It received FDA 510(k) clearance on 1994-10-20 under 510(k) number K941391. The device is classified under product code GBT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INFLATABLE RETENTION CUFF SPECULUM?

INFLATABLE RETENTION CUFF SPECULUM is a medical device that received FDA 510(k) clearance on 1994-10-20. The listed applicant is Innovatec Medical Corp.. The 510(k) number is K941391.

When did INFLATABLE RETENTION CUFF SPECULUM receive FDA 510(k) clearance?

INFLATABLE RETENTION CUFF SPECULUM received FDA 510(k) clearance on 1994-10-20, under 510(k) number K941391.

Who is the listed applicant for INFLATABLE RETENTION CUFF SPECULUM?

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

What is the FDA product code for INFLATABLE RETENTION CUFF SPECULUM?

The FDA product code for INFLATABLE RETENTION CUFF SPECULUM is GBT.

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Related Devices (Code: GBT)

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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