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FDA 510(k)

MODEL 709 BIPOLAR MICRO COAGULATOR

K-Number: K863701 · 1986-10-14

ApplicantBergen Mfg.
Decision Date1986-10-14
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODEL 709 BIPOLAR MICRO COAGULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Bergen Mfg.. It received FDA 510(k) clearance on 1986-10-14 under 510(k) number K863701. 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 MODEL 709 BIPOLAR MICRO COAGULATOR?

MODEL 709 BIPOLAR MICRO COAGULATOR is a medical device that received FDA 510(k) clearance on 1986-10-14. The listed applicant is Bergen Mfg.. The 510(k) number is K863701.

When did MODEL 709 BIPOLAR MICRO COAGULATOR receive FDA 510(k) clearance?

MODEL 709 BIPOLAR MICRO COAGULATOR received FDA 510(k) clearance on 1986-10-14, under 510(k) number K863701.

Who is the listed applicant for MODEL 709 BIPOLAR MICRO COAGULATOR?

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

What is the FDA product code for MODEL 709 BIPOLAR MICRO COAGULATOR?

The FDA product code for MODEL 709 BIPOLAR MICRO COAGULATOR 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.

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Other records listing Bergen Mfg. 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.

K972299BERGEN MODEL 500 ELECTROSURGERY GENERATORK964736BERGEN 610 BIPOLAR COAGULATORK945861BERGEN 710 ESU

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

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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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