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FDA 510(k)

SWAN VALLEY MEDICAL TRANURETHRAL SUPRAPUBIC ENDO-CYSTOSTOMY (T-SPEC) SURGICAL SYSTEM

K-Number: K120127 · 2012-10-26

ApplicantSwan Valley Medical, Incorporated
Decision Date2012-10-26
Product CodeKOB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SWAN VALLEY MEDICAL TRANURETHRAL SUPRAPUBIC ENDO-CYSTOSTOMY (T-SPEC) SURGICAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Swan Valley Medical, Incorporated. It received FDA 510(k) clearance on 2012-10-26 under 510(k) number K120127. The device is classified under product code KOB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SWAN VALLEY MEDICAL TRANURETHRAL SUPRAPUBIC ENDO-CYSTOSTOMY (T-SPEC) SURGICAL SYSTEM?

SWAN VALLEY MEDICAL TRANURETHRAL SUPRAPUBIC ENDO-CYSTOSTOMY (T-SPEC) SURGICAL SYSTEM is a medical device that received FDA 510(k) clearance on 2012-10-26. The listed applicant is Swan Valley Medical, Incorporated. The 510(k) number is K120127.

When did SWAN VALLEY MEDICAL TRANURETHRAL SUPRAPUBIC ENDO-CYSTOSTOMY (T-SPEC) SURGICAL SYSTEM receive FDA 510(k) clearance?

SWAN VALLEY MEDICAL TRANURETHRAL SUPRAPUBIC ENDO-CYSTOSTOMY (T-SPEC) SURGICAL SYSTEM received FDA 510(k) clearance on 2012-10-26, under 510(k) number K120127.

Who is the listed applicant for SWAN VALLEY MEDICAL TRANURETHRAL SUPRAPUBIC ENDO-CYSTOSTOMY (T-SPEC) SURGICAL SYSTEM?

The FDA 510(k) record lists Swan Valley Medical, Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SWAN VALLEY MEDICAL TRANURETHRAL SUPRAPUBIC ENDO-CYSTOSTOMY (T-SPEC) SURGICAL SYSTEM?

The FDA product code for SWAN VALLEY MEDICAL TRANURETHRAL SUPRAPUBIC ENDO-CYSTOSTOMY (T-SPEC) SURGICAL SYSTEM is KOB.

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Related Devices (Code: KOB)

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.

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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.

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