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FDA 510(k)

KOBOLD SURE-GUIDE VAGINAL CYLINDER SET, STUMP VAGINAL CYLINDER SET, MIAMI CYLINDER SET

K-Number: K123941 · 2013-04-30

ApplicantSpencer Fillmore
Decision Date2013-04-30
Product CodeJAQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

KOBOLD SURE-GUIDE VAGINAL CYLINDER SET, STUMP VAGINAL CYLINDER SET, MIAMI CYLINDER SET is the device name listed in this FDA 510(k) record. The listed applicant is Spencer Fillmore. It received FDA 510(k) clearance on 2013-04-30 under 510(k) number K123941. The device is classified under product code JAQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KOBOLD SURE-GUIDE VAGINAL CYLINDER SET, STUMP VAGINAL CYLINDER SET, MIAMI CYLINDER SET?

KOBOLD SURE-GUIDE VAGINAL CYLINDER SET, STUMP VAGINAL CYLINDER SET, MIAMI CYLINDER SET is a medical device that received FDA 510(k) clearance on 2013-04-30. The listed applicant is Spencer Fillmore. The 510(k) number is K123941.

When did KOBOLD SURE-GUIDE VAGINAL CYLINDER SET, STUMP VAGINAL CYLINDER SET, MIAMI CYLINDER SET receive FDA 510(k) clearance?

KOBOLD SURE-GUIDE VAGINAL CYLINDER SET, STUMP VAGINAL CYLINDER SET, MIAMI CYLINDER SET received FDA 510(k) clearance on 2013-04-30, under 510(k) number K123941.

Who is the listed applicant for KOBOLD SURE-GUIDE VAGINAL CYLINDER SET, STUMP VAGINAL CYLINDER SET, MIAMI CYLINDER SET?

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

What is the FDA product code for KOBOLD SURE-GUIDE VAGINAL CYLINDER SET, STUMP VAGINAL CYLINDER SET, MIAMI CYLINDER SET?

The FDA product code for KOBOLD SURE-GUIDE VAGINAL CYLINDER SET, STUMP VAGINAL CYLINDER SET, MIAMI CYLINDER SET is JAQ.

Related Clinical Trials

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Other records listing Spencer Fillmore 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.

K123912KOBOLD FLETCHER TYPE APPLICATOR SET, KOBOLD HENSCHKE TYPE APPLICATOR SET

Related Devices (Code: JAQ)

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.

K262383LumenCare AzureNucletron B.V.K252717MAASTRO Rectal Applicator SetVarian Medical SystemsK251037Rectal ApplicatorNucletron B.V.K252884Guided Aarhus Applicator SetVarian Medical SystemsK250299CT/ MR Tandem and Ovoid SetVarian Medical Systems, Inc.K250289Intracavitary/Interstitial SystemVarian Medical Systems

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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