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FDA 510(k)

AMS SPHINCTER 800 URINARY PROSTHESIS

K-Number: K912934 · 1992-03-18

ApplicantAmerican Medical Systems, Inc.
Decision Date1992-03-18
Product CodeFAG
DecisionSubstantially Equivalent

Device Summary

AMS SPHINCTER 800 URINARY PROSTHESIS 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 1992-03-18 under 510(k) number K912934. The device is classified under product code FAG. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMS SPHINCTER 800 URINARY PROSTHESIS?

AMS SPHINCTER 800 URINARY PROSTHESIS is a medical device that received FDA 510(k) clearance on 1992-03-18. The listed applicant is American Medical Systems, Inc.. The 510(k) number is K912934.

When did AMS SPHINCTER 800 URINARY PROSTHESIS receive FDA 510(k) clearance?

AMS SPHINCTER 800 URINARY PROSTHESIS received FDA 510(k) clearance on 1992-03-18, under 510(k) number K912934.

Who is the listed applicant for AMS SPHINCTER 800 URINARY PROSTHESIS?

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 SPHINCTER 800 URINARY PROSTHESIS?

The FDA product code for AMS SPHINCTER 800 URINARY PROSTHESIS is FAG.

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Other records listing American Medical Systems, 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.

K132655RETROARC RETROPUBIC SLING SYSTEMK112842AMS ELEVATE PCK100807MINIARC PRECISE SINGLE-INCISION SLING SYSTEM MODEL: 720181, 720191K092735GREENLIGHT XPS LASER SYSTEMK090934PFR SLING SYSTEM, PART OF THE AMS PELVIC FLOOR REPAIR SYSTEMK090663AMS SPECTRA CONCEALABLE PENILE PROSTHESIS

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Related Devices (Code: FAG)

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.

K821627THE ARTIFICIAL URINARY SPHINCTERAmerican Medical Systems, 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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