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FDA 510(k)

ArcSP Suprapubic Sling System

K-Number: K222293 · 2022-09-21

ApplicantUrocure, LLC
Decision Date2022-09-21
Product CodeOTN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ArcSP Suprapubic Sling System is the device name listed in this FDA 510(k) record. The listed applicant is Urocure, LLC. It received FDA 510(k) clearance on 2022-09-21 under 510(k) number K222293. 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 ArcSP Suprapubic Sling System?

ArcSP Suprapubic Sling System is a medical device that received FDA 510(k) clearance on 2022-09-21. The listed applicant is Urocure, LLC. The 510(k) number is K222293.

When did ArcSP Suprapubic Sling System receive FDA 510(k) clearance?

ArcSP Suprapubic Sling System received FDA 510(k) clearance on 2022-09-21, under 510(k) number K222293.

Who is the listed applicant for ArcSP Suprapubic Sling System?

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

What is the FDA product code for ArcSP Suprapubic Sling System?

The FDA product code for ArcSP Suprapubic Sling System is OTN.

Other records listing Urocure, LLC 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.

K222468ArcTO Transobturator Sling SystemK183134ArcTV Transvaginal Sling System

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 CorporationK222468ArcTO 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, LLCK201686GYNECARE TVT™ System, GYNECARE TVT™ with Abdominal Guides System, GYNECARE TVT™ Introducer and Catheter Guide, GYNECARE TVT EXACT™ Continence System and Trocar, GYNECARE TVT™ Obturator System and Passers and Winged Guide, GYNECARE TVT ABBREVO™ Continence System and Passers and Winged GuideETHICON, Inc.

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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