Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

System, Applicator, Radionuclide, Remote Controlled

K-Number: K170203 · 2017-06-01

ApplicantKobold, LLC
Decision Date2017-06-01
Product CodeJAQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

System, Applicator, Radionuclide, Remote Controlled is the device name listed in this FDA 510(k) record. The listed applicant is Kobold, LLC. It received FDA 510(k) clearance on 2017-06-01 under 510(k) number K170203. 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 System, Applicator, Radionuclide, Remote Controlled?

System, Applicator, Radionuclide, Remote Controlled is a medical device that received FDA 510(k) clearance on 2017-06-01. The listed applicant is Kobold, LLC. The 510(k) number is K170203.

When did System, Applicator, Radionuclide, Remote Controlled receive FDA 510(k) clearance?

System, Applicator, Radionuclide, Remote Controlled received FDA 510(k) clearance on 2017-06-01, under 510(k) number K170203.

Who is the listed applicant for System, Applicator, Radionuclide, Remote Controlled?

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

What is the FDA product code for System, Applicator, Radionuclide, Remote Controlled?

The FDA product code for System, Applicator, Radionuclide, Remote Controlled is JAQ.

Other records listing Kobold, 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.

K160610Kobold Fletcher-model Tandem and Ovoid Applicator Set, Kobold Henschke-model Tandem and Ovoid Applicator Set, Kobold Vaginal Cylinder Applicator Set, Kobold Miami Cylinder 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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑