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FDA 510(k)

KLEIN WIRE TIGHTENER/BIONIC WIRE

K-Number: K833726 · 1983-12-22

ApplicantBionic Instrument Corp.
Decision Date1983-12-22
Product CodeHXS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

KLEIN WIRE TIGHTENER/BIONIC WIRE is the device name listed in this FDA 510(k) record. The listed applicant is Bionic Instrument Corp.. It received FDA 510(k) clearance on 1983-12-22 under 510(k) number K833726. The device is classified under product code HXS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KLEIN WIRE TIGHTENER/BIONIC WIRE?

KLEIN WIRE TIGHTENER/BIONIC WIRE is a medical device that received FDA 510(k) clearance on 1983-12-22. The listed applicant is Bionic Instrument Corp.. The 510(k) number is K833726.

When did KLEIN WIRE TIGHTENER/BIONIC WIRE receive FDA 510(k) clearance?

KLEIN WIRE TIGHTENER/BIONIC WIRE received FDA 510(k) clearance on 1983-12-22, under 510(k) number K833726.

Who is the listed applicant for KLEIN WIRE TIGHTENER/BIONIC WIRE?

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

What is the FDA product code for KLEIN WIRE TIGHTENER/BIONIC WIRE?

The FDA product code for KLEIN WIRE TIGHTENER/BIONIC WIRE is HXS.

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Related Devices (Code: HXS)

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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