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FDA 510(k)

SURGICAL PENCIL/ ELECTROSURGICAL PENCIL

K-Number: K873595 · 1987-10-26

Decision Date1987-10-26
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGICAL PENCIL/ ELECTROSURGICAL PENCIL is the device name listed in this FDA 510(k) record. The listed applicant is Yuntek International, Inc.. It received FDA 510(k) clearance on 1987-10-26 under 510(k) number K873595. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGICAL PENCIL/ ELECTROSURGICAL PENCIL?

SURGICAL PENCIL/ ELECTROSURGICAL PENCIL is a medical device that received FDA 510(k) clearance on 1987-10-26. The listed applicant is Yuntek International, Inc.. The 510(k) number is K873595.

When did SURGICAL PENCIL/ ELECTROSURGICAL PENCIL receive FDA 510(k) clearance?

SURGICAL PENCIL/ ELECTROSURGICAL PENCIL received FDA 510(k) clearance on 1987-10-26, under 510(k) number K873595.

Who is the listed applicant for SURGICAL PENCIL/ ELECTROSURGICAL PENCIL?

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

What is the FDA product code for SURGICAL PENCIL/ ELECTROSURGICAL PENCIL?

The FDA product code for SURGICAL PENCIL/ ELECTROSURGICAL PENCIL is GEI.

Related Clinical Trials

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.

Other records listing Yuntek International, Inc. as applicant

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.

Related Devices (Code: GEI)

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.

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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