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FDA 510(k)

HYBRISONIC SHEATH

K-Number: K983985 · 1999-02-25

ApplicantSonotech, Inc.
Decision Date1999-02-25
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HYBRISONIC SHEATH is the device name listed in this FDA 510(k) record. The listed applicant is Sonotech, Inc.. It received FDA 510(k) clearance on 1999-02-25 under 510(k) number K983985. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYBRISONIC SHEATH?

HYBRISONIC SHEATH is a medical device that received FDA 510(k) clearance on 1999-02-25. The listed applicant is Sonotech, Inc.. The 510(k) number is K983985.

When did HYBRISONIC SHEATH receive FDA 510(k) clearance?

HYBRISONIC SHEATH received FDA 510(k) clearance on 1999-02-25, under 510(k) number K983985.

Who is the listed applicant for HYBRISONIC SHEATH?

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

What is the FDA product code for HYBRISONIC SHEATH?

The FDA product code for HYBRISONIC SHEATH is ITX.

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Other records listing Sonotech, Inc. as applicant

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Related Devices (Code: ITX)

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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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