FDA 510(k)

SURGITEL

K-Number: K934494 · 1994-01-25

Decision Date1994-01-25

Product CodeHOH

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

SURGITEL is the device name listed in this FDA 510(k) record. The listed applicant is General Scientific Corp.. It received FDA 510(k) clearance on 1994-01-25 under 510(k) number K934494. The device is classified under product code HOH. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGITEL?

SURGITEL is a medical device that received FDA 510(k) clearance on 1994-01-25. The listed applicant is General Scientific Corp.. The 510(k) number is K934494.

When did SURGITEL receive FDA 510(k) clearance?

SURGITEL received FDA 510(k) clearance on 1994-01-25, under 510(k) number K934494.

Who is the listed applicant for SURGITEL?

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

What is the FDA product code for SURGITEL?

The FDA product code for SURGITEL is HOH.

Related Clinical Trials

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Related Devices (Code: HOH)

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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.