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FDA 510(k)

MENTOR ARIS SUPRAPUBIC SURGICAL KIT

K-Number: K053296 · 2005-12-15

ApplicantMentor Corporation
Decision Date2005-12-15
Product CodeOTN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MENTOR ARIS SUPRAPUBIC SURGICAL KIT is the device name listed in this FDA 510(k) record. The listed applicant is Mentor Corporation. It received FDA 510(k) clearance on 2005-12-15 under 510(k) number K053296. The device is classified under product code OTN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MENTOR ARIS SUPRAPUBIC SURGICAL KIT?

MENTOR ARIS SUPRAPUBIC SURGICAL KIT is a medical device that received FDA 510(k) clearance on 2005-12-15. The listed applicant is Mentor Corporation. The 510(k) number is K053296.

When did MENTOR ARIS SUPRAPUBIC SURGICAL KIT receive FDA 510(k) clearance?

MENTOR ARIS SUPRAPUBIC SURGICAL KIT received FDA 510(k) clearance on 2005-12-15, under 510(k) number K053296.

Who is the listed applicant for MENTOR ARIS SUPRAPUBIC SURGICAL KIT?

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

What is the FDA product code for MENTOR ARIS SUPRAPUBIC SURGICAL KIT?

The FDA product code for MENTOR ARIS SUPRAPUBIC SURGICAL KIT is OTN.

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Other records listing Mentor Corporation 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.

K062421MENTOR RESTERILIZABLE GEL BREAST IMPLANT SIZERK052440MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETERK050148MENTOR ARIS TRANS-OBTURATOR TAPE AND SURGICAL KIT

Related Devices (Code: OTN)

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.

K231549Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra SystemBoston Scientific CorporationK222293ArcSP Suprapubic Sling SystemUrocure, LLCK222468ArcTO Transobturator Sling SystemUrocure, LLCK211975Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara Blue TV EZ 2.7 SystemCaldera Medical, Inc.K211223Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra SystemBoston Scientific CorporationK210087Athena Surgical RMUS SystemAthena Surgical, LLC

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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