Mentor Gemini Hemostatic Eraser

FDA 510(k) K971538 · Mentor Ophthalmics, Inc.

Substantially Equivalent

510(k) numberK971538

Submission

Device name
Mentor Gemini Hemostatic Eraser
Applicant
Mentor Ophthalmics, Inc.
Norwell, MA, US
Received
April 28, 1997
Decision date
July 14, 1997
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HQO – Unit, Cautery, Thermal, Ac-Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 886.4115
Specialty
Ophthalmic

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Questions and answers

When was Mentor Gemini Hemostatic Eraser cleared by the FDA?

Mentor Gemini Hemostatic Eraser (K971538) received a 510(k) decision of Substantially Equivalent on July 14, 1997, 77 days after the submission was received.

What is the product code of K971538?

The FDA product code is HQO – Unit, Cautery, Thermal, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.4115.