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FDA 510(k)

AMS FASCIAL-ANCHORING SYSTEM

K-Number: K010277 · 2001-03-26

ApplicantAmerican Medical Systems, Inc.
Decision Date2001-03-26
Product CodeNEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AMS FASCIAL-ANCHORING 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 2001-03-26 under 510(k) number K010277. The device is classified under product code NEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMS FASCIAL-ANCHORING SYSTEM?

AMS FASCIAL-ANCHORING SYSTEM is a medical device that received FDA 510(k) clearance on 2001-03-26. The listed applicant is American Medical Systems, Inc.. The 510(k) number is K010277.

When did AMS FASCIAL-ANCHORING SYSTEM receive FDA 510(k) clearance?

AMS FASCIAL-ANCHORING SYSTEM received FDA 510(k) clearance on 2001-03-26, under 510(k) number K010277.

Who is the listed applicant for AMS FASCIAL-ANCHORING 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 FASCIAL-ANCHORING SYSTEM?

The FDA product code for AMS FASCIAL-ANCHORING SYSTEM is NEH.

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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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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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