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)

Disposable guides KDNG00

K-Number: K180970 · 2018-07-10

ApplicantKoelis
Decision Date2018-07-10
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Disposable guides KDNG00 is the device name listed in this FDA 510(k) record. The listed applicant is Koelis. It received FDA 510(k) clearance on 2018-07-10 under 510(k) number K180970. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Disposable guides KDNG00?

Disposable guides KDNG00 is a medical device that received FDA 510(k) clearance on 2018-07-10. The listed applicant is Koelis. The 510(k) number is K180970.

When did Disposable guides KDNG00 receive FDA 510(k) clearance?

Disposable guides KDNG00 received FDA 510(k) clearance on 2018-07-10, under 510(k) number K180970.

Who is the listed applicant for Disposable guides KDNG00?

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

What is the FDA product code for Disposable guides KDNG00?

The FDA product code for Disposable guides KDNG00 is ITX.

Other records listing Koelis 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.

K171040Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO rangeK170521TRINITY/3D PROSTATE SUITEK160357TRINITY

Related Devices (Code: ITX)

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.

K261170BA-004CCFujifilm CorporationK254143EM-TECH Passive Ultrasound Probe StrapEM-TECH Solutions, Inc.K260161SmartGuide Disposable Guides and GridsUC-CARE , Ltd.K262474ND Needle Guidance SystemAccurate Access, LLCK261014Accuro® 3S Needle Guide KitRivanna Medical, Inc.K250883ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R)Olympus Medical Systems Corporation

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.

↑