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FDA 510(k)

LTN - LAPAROSCOPIC SURGICAL MESH

K-Number: K130817 · 2013-04-17

ApplicantLifecell Corp.
Decision Date2013-04-17
Product CodeOXK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LTN - LAPAROSCOPIC SURGICAL MESH is the device name listed in this FDA 510(k) record. The listed applicant is Lifecell Corp.. It received FDA 510(k) clearance on 2013-04-17 under 510(k) number K130817. The device is classified under product code OXK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LTN - LAPAROSCOPIC SURGICAL MESH?

LTN - LAPAROSCOPIC SURGICAL MESH is a medical device that received FDA 510(k) clearance on 2013-04-17. The listed applicant is Lifecell Corp.. The 510(k) number is K130817.

When did LTN - LAPAROSCOPIC SURGICAL MESH receive FDA 510(k) clearance?

LTN - LAPAROSCOPIC SURGICAL MESH received FDA 510(k) clearance on 2013-04-17, under 510(k) number K130817.

Who is the listed applicant for LTN - LAPAROSCOPIC SURGICAL MESH?

The FDA 510(k) record lists Lifecell Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LTN - LAPAROSCOPIC SURGICAL MESH?

The FDA product code for LTN - LAPAROSCOPIC SURGICAL MESH is OXK.

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Other records listing Lifecell Corp. 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.

K112534LIFECELL TISSUE EXPANDERK121289LTM-LABAROSCOPIC SURGICAL MESHK082176LTM-BPS SURGICAL MESHK082103LTM WOUND DRESSINGK080353LTM-T SURGICAL MESHK071986LTM-RC SURGICAL MESH

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Related Devices (Code: OXK)

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.

K121289LTM-LABAROSCOPIC SURGICAL MESHLifecell Corp.

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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