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FDA 510(k)

AMS MAINSTAY UROLOGIC BONE ANCHOR

K-Number: K971332 · 1997-07-09

ApplicantAmerican Medical Systems, Inc.
Decision Date1997-07-09
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AMS MAINSTAY UROLOGIC BONE ANCHOR is the device name listed in this FDA 510(k) record. The listed applicant is American Medical Systems, Inc.. It received FDA 510(k) clearance on 1997-07-09 under 510(k) number K971332. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMS MAINSTAY UROLOGIC BONE ANCHOR?

AMS MAINSTAY UROLOGIC BONE ANCHOR is a medical device that received FDA 510(k) clearance on 1997-07-09. The listed applicant is American Medical Systems, Inc.. The 510(k) number is K971332.

When did AMS MAINSTAY UROLOGIC BONE ANCHOR receive FDA 510(k) clearance?

AMS MAINSTAY UROLOGIC BONE ANCHOR received FDA 510(k) clearance on 1997-07-09, under 510(k) number K971332.

Who is the listed applicant for AMS MAINSTAY UROLOGIC BONE ANCHOR?

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

What is the FDA product code for AMS MAINSTAY UROLOGIC BONE ANCHOR?

The FDA product code for AMS MAINSTAY UROLOGIC BONE ANCHOR is MBI.

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Other records listing American Medical Systems, Inc. as applicant

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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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