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FDA 510(k)

BI-POLAR FORCEPS

K-Number: K854864 · 1985-12-24

ApplicantBirtcher Corp.
Decision Date1985-12-24
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BI-POLAR FORCEPS is the device name listed in this FDA 510(k) record. The listed applicant is Birtcher Corp.. It received FDA 510(k) clearance on 1985-12-24 under 510(k) number K854864. 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 BI-POLAR FORCEPS?

BI-POLAR FORCEPS is a medical device that received FDA 510(k) clearance on 1985-12-24. The listed applicant is Birtcher Corp.. The 510(k) number is K854864.

When did BI-POLAR FORCEPS receive FDA 510(k) clearance?

BI-POLAR FORCEPS received FDA 510(k) clearance on 1985-12-24, under 510(k) number K854864.

Who is the listed applicant for BI-POLAR FORCEPS?

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 BI-POLAR FORCEPS?

The FDA product code for BI-POLAR FORCEPS 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 & 33K850943MODEL 775 BIPOLAR COAGULATORK850668ELECTROSURGICAL UNIT 774

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Related Devices (Code: GEI)

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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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