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FDA 510(k)

AMS PELVIC FLOOR REPAIR SYSTEM

K-Number: K051485 · 2005-08-03

ApplicantAmerican Medical Systems, Inc.
Decision Date2005-08-03
Product CodeOTO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AMS PELVIC FLOOR REPAIR SYSTEM 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 2005-08-03 under 510(k) number K051485. The device is classified under product code OTO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMS PELVIC FLOOR REPAIR SYSTEM?

AMS PELVIC FLOOR REPAIR SYSTEM is a medical device that received FDA 510(k) clearance on 2005-08-03. The listed applicant is American Medical Systems, Inc.. The 510(k) number is K051485.

When did AMS PELVIC FLOOR REPAIR SYSTEM receive FDA 510(k) clearance?

AMS PELVIC FLOOR REPAIR SYSTEM received FDA 510(k) clearance on 2005-08-03, under 510(k) number K051485.

Who is the listed applicant for AMS PELVIC FLOOR REPAIR SYSTEM?

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 PELVIC FLOOR REPAIR SYSTEM?

The FDA product code for AMS PELVIC FLOOR REPAIR SYSTEM is OTO.

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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: OTO)

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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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