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FDA 510(k)

BLUE SUI SLING

K-Number: K121754 · 2012-10-10

ApplicantBoston Scientific Corp
Decision Date2012-10-10
Product CodeOTN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BLUE SUI SLING is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corp. It received FDA 510(k) clearance on 2012-10-10 under 510(k) number K121754. 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 BLUE SUI SLING?

BLUE SUI SLING is a medical device that received FDA 510(k) clearance on 2012-10-10. The listed applicant is Boston Scientific Corp. The 510(k) number is K121754.

When did BLUE SUI SLING receive FDA 510(k) clearance?

BLUE SUI SLING received FDA 510(k) clearance on 2012-10-10, under 510(k) number K121754.

Who is the listed applicant for BLUE SUI SLING?

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

What is the FDA product code for BLUE SUI SLING?

The FDA product code for BLUE SUI SLING is OTN.

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Other records listing Boston Scientific Corp as applicant

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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

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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