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FDA 510(k)

MENTOR(R) DURASTAT(TM) AUTOCLAV BIPOLAR HEMOSTAT

K-Number: K903878 · 1990-11-05

ApplicantMentor O & O, Inc.
Decision Date1990-11-05
Product CodeHQQ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MENTOR(R) DURASTAT(TM) AUTOCLAV BIPOLAR HEMOSTAT is the device name listed in this FDA 510(k) record. The listed applicant is Mentor O & O, Inc.. It received FDA 510(k) clearance on 1990-11-05 under 510(k) number K903878. The device is classified under product code HQQ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MENTOR(R) DURASTAT(TM) AUTOCLAV BIPOLAR HEMOSTAT?

MENTOR(R) DURASTAT(TM) AUTOCLAV BIPOLAR HEMOSTAT is a medical device that received FDA 510(k) clearance on 1990-11-05. The listed applicant is Mentor O & O, Inc.. The 510(k) number is K903878.

When did MENTOR(R) DURASTAT(TM) AUTOCLAV BIPOLAR HEMOSTAT receive FDA 510(k) clearance?

MENTOR(R) DURASTAT(TM) AUTOCLAV BIPOLAR HEMOSTAT received FDA 510(k) clearance on 1990-11-05, under 510(k) number K903878.

Who is the listed applicant for MENTOR(R) DURASTAT(TM) AUTOCLAV BIPOLAR HEMOSTAT?

The FDA 510(k) record lists Mentor O & O, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MENTOR(R) DURASTAT(TM) AUTOCLAV BIPOLAR HEMOSTAT?

The FDA product code for MENTOR(R) DURASTAT(TM) AUTOCLAV BIPOLAR HEMOSTAT is HQQ.

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Other records listing Mentor O & O, Inc. 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.

K955245MENTOR MERIDIAN PHACOEMULSIFICATION SYSTEMK934320MENTOR WET-FIELD HEMOSTATIC ERASER BIPOLAR INSTRUMENT, 20 GAUGE WITH EXTRUSION ASPIRATIONK912904MENTOR ODYSSEY PHACOEMULSIFICATION SYSTEMK915340MENTOR HORIZON LOW VISION MAGNIFIERK910637MENTOR(R) SUR-E-TROL(R)K911160MENTOR(R) WET-FIELD(R) II AC COAGULATOR, 22-1305

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Related Devices (Code: HQQ)

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.

K910088SCITECH BI-MANUAL ADAPTER CLIPSScitech Industries PartnershipK881001MENTOR WET-FIELD*II COAGULATORMentor O & O, Inc.

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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