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FDA 510(k)

BERGEN 610 BIPOLAR COAGULATOR

K-Number: K964736 · 1997-02-27

ApplicantBergen Mfg.
Decision Date1997-02-27
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BERGEN 610 BIPOLAR 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 1997-02-27 under 510(k) number K964736. 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 BERGEN 610 BIPOLAR COAGULATOR?

BERGEN 610 BIPOLAR COAGULATOR is a medical device that received FDA 510(k) clearance on 1997-02-27. The listed applicant is Bergen Mfg.. The 510(k) number is K964736.

When did BERGEN 610 BIPOLAR COAGULATOR receive FDA 510(k) clearance?

BERGEN 610 BIPOLAR COAGULATOR received FDA 510(k) clearance on 1997-02-27, under 510(k) number K964736.

Who is the listed applicant for BERGEN 610 BIPOLAR 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 BERGEN 610 BIPOLAR COAGULATOR?

The FDA product code for BERGEN 610 BIPOLAR 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 GENERATORK945861BERGEN 710 ESUK863701MODEL 709 BIPOLAR MICRO COAGULATOR

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.

K261959Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Rocker Switch (0703-047-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Rocker Switch, Bulk Non-Sterile (0703-047-102)Stryker InstrumentsK254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLCK261070LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coatedCovidien, LLCK254185Potenza PrimeJeisys Medical IncorporatedK262364Ellian Enigma RF DeviceEllian CorpK253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.

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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