FDA 510(k)

JLK-PWI

K-Number: K242709 · 2024-11-04

Decision Date2024-11-04

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

JLK-PWI is the device name listed in this FDA 510(k) record. The listed applicant is JLK, Inc.. It received FDA 510(k) clearance on 2024-11-04 under 510(k) number K242709. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JLK-PWI?

JLK-PWI is a medical device that received FDA 510(k) clearance on 2024-11-04. The listed applicant is JLK, Inc.. The 510(k) number is K242709.

When did JLK-PWI receive FDA 510(k) clearance?

JLK-PWI received FDA 510(k) clearance on 2024-11-04, under 510(k) number K242709.

Who is the listed applicant for JLK-PWI?

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

What is the FDA product code for JLK-PWI?

The FDA product code for JLK-PWI is LLZ.

Other records listing JLK, Inc. 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.

K252421JLK-NCCT K243611JLK-SDH K250348JLK-AILink K243363JLK-ICH K242556JLK-CTP K241480JBS-LVO

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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.