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FDA 510(k)

ISOLA BAND CLAMP

K-Number: K010972 · 2001-06-12

ApplicantDepuyacromed
Decision Date2001-06-12
Product CodeMNI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ISOLA BAND CLAMP is the device name listed in this FDA 510(k) record. The listed applicant is Depuyacromed. It received FDA 510(k) clearance on 2001-06-12 under 510(k) number K010972. The device is classified under product code MNI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ISOLA BAND CLAMP?

ISOLA BAND CLAMP is a medical device that received FDA 510(k) clearance on 2001-06-12. The listed applicant is Depuyacromed. The 510(k) number is K010972.

When did ISOLA BAND CLAMP receive FDA 510(k) clearance?

ISOLA BAND CLAMP received FDA 510(k) clearance on 2001-06-12, under 510(k) number K010972.

Who is the listed applicant for ISOLA BAND CLAMP?

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

What is the FDA product code for ISOLA BAND CLAMP?

The FDA product code for ISOLA BAND CLAMP is MNI.

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Related Devices (Code: MNI)

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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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