FDA 510(k)

AJUST HELICAL ADJUSTABLE SINGLE-INCISION SLING

K-Number: K123179 · 2012-11-02

Decision Date2012-11-02

Product CodePAH

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

AJUST HELICAL ADJUSTABLE SINGLE-INCISION SLING is the device name listed in this FDA 510(k) record. The listed applicant is C.R. Bard, Inc.. It received FDA 510(k) clearance on 2012-11-02 under 510(k) number K123179. The device is classified under product code PAH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AJUST HELICAL ADJUSTABLE SINGLE-INCISION SLING?

AJUST HELICAL ADJUSTABLE SINGLE-INCISION SLING is a medical device that received FDA 510(k) clearance on 2012-11-02. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K123179.

When did AJUST HELICAL ADJUSTABLE SINGLE-INCISION SLING receive FDA 510(k) clearance?

AJUST HELICAL ADJUSTABLE SINGLE-INCISION SLING received FDA 510(k) clearance on 2012-11-02, under 510(k) number K123179.

Who is the listed applicant for AJUST HELICAL ADJUSTABLE SINGLE-INCISION SLING?

The FDA 510(k) record lists C.R. Bard, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AJUST HELICAL ADJUSTABLE SINGLE-INCISION SLING?

The FDA product code for AJUST HELICAL ADJUSTABLE SINGLE-INCISION SLING is PAH.

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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.