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FDA 510(k)

ENDOTOME

K-Number: K790645 · 1979-04-23

ApplicantBerkeley Bio-Engineering
Decision Date1979-04-23
Product CodeHSZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ENDOTOME is the device name listed in this FDA 510(k) record. The listed applicant is Berkeley Bio-Engineering. It received FDA 510(k) clearance on 1979-04-23 under 510(k) number K790645. The device is classified under product code HSZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOTOME?

ENDOTOME is a medical device that received FDA 510(k) clearance on 1979-04-23. The listed applicant is Berkeley Bio-Engineering. The 510(k) number is K790645.

When did ENDOTOME receive FDA 510(k) clearance?

ENDOTOME received FDA 510(k) clearance on 1979-04-23, under 510(k) number K790645.

Who is the listed applicant for ENDOTOME?

The FDA 510(k) record lists Berkeley Bio-Engineering as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENDOTOME?

The FDA product code for ENDOTOME is HSZ.

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Other records listing Berkeley Bio-Engineering 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.

K771711BIOTOMEK771644FRAGMATOME MODEL 820K770292MONITOR, FETAL HEART, MODEL 1980

Related Devices (Code: HSZ)

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.

K991588EMS SWISS ORTHOCLAST(Ems Sa) Electro Medical SystemsK972860CURVTEK TSR SYSTEMBiolectron, Inc.K970345ALIGNMENT INSTRUMENTRichard Wolf Medical Instruments Corp.K955084ASPACH 65,000 (MODIFICATION)The Anspach Effort, Inc.K954080SODEM HIGH SPEED SYSTEMSodem Diffusion SAK944590ETHICON DRILL BIT AND DRILL GUIDEETHICON, Inc.

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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