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FDA 510(k)

MENTOR GEMINI HEMOSTATIC ERASER

K-Number: K971538 · 1997-07-14

ApplicantMentor Ophthalmics, Inc.
Decision Date1997-07-14
Product CodeHQO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MENTOR GEMINI HEMOSTATIC ERASER is the device name listed in this FDA 510(k) record. The listed applicant is Mentor Ophthalmics, Inc.. It received FDA 510(k) clearance on 1997-07-14 under 510(k) number K971538. The device is classified under product code HQO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MENTOR GEMINI HEMOSTATIC ERASER?

MENTOR GEMINI HEMOSTATIC ERASER is a medical device that received FDA 510(k) clearance on 1997-07-14. The listed applicant is Mentor Ophthalmics, Inc.. The 510(k) number is K971538.

When did MENTOR GEMINI HEMOSTATIC ERASER receive FDA 510(k) clearance?

MENTOR GEMINI HEMOSTATIC ERASER received FDA 510(k) clearance on 1997-07-14, under 510(k) number K971538.

Who is the listed applicant for MENTOR GEMINI HEMOSTATIC ERASER?

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

What is the FDA product code for MENTOR GEMINI HEMOSTATIC ERASER?

The FDA product code for MENTOR GEMINI HEMOSTATIC ERASER is HQO.

Related Clinical Trials

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Other records listing Mentor Ophthalmics, 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.

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Related Devices (Code: HQO)

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.

K070871STARION UNIVERSAL POWER SUPPLYStarion InstrumentsK043155STARION UNIVERSAL POWER SUPPLY (UPS)Starion InstrumentsK002341THERMAL CAUTERY UNIT, MODEL 150Geiger Medical Technologies, Inc.K000893AC POWERED THERMAL CAUTERY UNITStarion InstrumentsK962135D.O.R.C. MICRODIATHERMY SYSTEMDutch Ophthalmic USA, Inc.K943031BIPOLAR ELECTROSURGICAL PENCILBoston Surgical Products, 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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