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FDA 510(k)

ELECTROSURGICAL UNIT 774

K-Number: K850668 · 1985-05-20

ApplicantBirtcher Corp.
Decision Date1985-05-20
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ELECTROSURGICAL UNIT 774 is the device name listed in this FDA 510(k) record. The listed applicant is Birtcher Corp.. It received FDA 510(k) clearance on 1985-05-20 under 510(k) number K850668. 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 ELECTROSURGICAL UNIT 774?

ELECTROSURGICAL UNIT 774 is a medical device that received FDA 510(k) clearance on 1985-05-20. The listed applicant is Birtcher Corp.. The 510(k) number is K850668.

When did ELECTROSURGICAL UNIT 774 receive FDA 510(k) clearance?

ELECTROSURGICAL UNIT 774 received FDA 510(k) clearance on 1985-05-20, under 510(k) number K850668.

Who is the listed applicant for ELECTROSURGICAL UNIT 774?

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

What is the FDA product code for ELECTROSURGICAL UNIT 774?

The FDA product code for ELECTROSURGICAL UNIT 774 is GEI.

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Other records listing Birtcher Corp. 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.

K881328MODEL 375 ECGK860687BIRT-A-SWITCH, DSP PUSH BUTTON, MODEL NO. 768K860718ELECTROSURGERY PENCIL, MODEL 767K854814SURGICAL CAUTERIES MODELS 775-11,12,13,31,32 & 33K854864BI-POLAR FORCEPSK850943MODEL 775 BIPOLAR COAGULATOR

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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.

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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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