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FDA 510(k)

TRANSURETHAL PROSTATOME DIAG TREATM PROPULSION SYS

K-Number: K855176 · 1986-05-13

ApplicantUrologic Surgical Devices Corp.
Decision Date1986-05-13
Product CodeFBK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

TRANSURETHAL PROSTATOME DIAG TREATM PROPULSION SYS is the device name listed in this FDA 510(k) record. The listed applicant is Urologic Surgical Devices Corp.. It received FDA 510(k) clearance on 1986-05-13 under 510(k) number K855176. The device is classified under product code FBK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRANSURETHAL PROSTATOME DIAG TREATM PROPULSION SYS?

TRANSURETHAL PROSTATOME DIAG TREATM PROPULSION SYS is a medical device that received FDA 510(k) clearance on 1986-05-13. The listed applicant is Urologic Surgical Devices Corp.. The 510(k) number is K855176.

When did TRANSURETHAL PROSTATOME DIAG TREATM PROPULSION SYS receive FDA 510(k) clearance?

TRANSURETHAL PROSTATOME DIAG TREATM PROPULSION SYS received FDA 510(k) clearance on 1986-05-13, under 510(k) number K855176.

Who is the listed applicant for TRANSURETHAL PROSTATOME DIAG TREATM PROPULSION SYS?

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

What is the FDA product code for TRANSURETHAL PROSTATOME DIAG TREATM PROPULSION SYS?

The FDA product code for TRANSURETHAL PROSTATOME DIAG TREATM PROPULSION SYS is FBK.

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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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