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FDA 510(k)

LM-9300 Plus Lithotripter

K-Number: K213772 · 2023-01-19

ApplicantLite-Med, Inc.
Decision Date2023-01-19
Product CodeLNS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

LM-9300 Plus Lithotripter is the device name listed in this FDA 510(k) record. The listed applicant is Lite-Med, Inc.. It received FDA 510(k) clearance on 2023-01-19 under 510(k) number K213772. The device is classified under product code LNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LM-9300 Plus Lithotripter?

LM-9300 Plus Lithotripter is a medical device that received FDA 510(k) clearance on 2023-01-19. The listed applicant is Lite-Med, Inc.. The 510(k) number is K213772.

When did LM-9300 Plus Lithotripter receive FDA 510(k) clearance?

LM-9300 Plus Lithotripter received FDA 510(k) clearance on 2023-01-19, under 510(k) number K213772.

Who is the listed applicant for LM-9300 Plus Lithotripter?

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

What is the FDA product code for LM-9300 Plus Lithotripter?

The FDA product code for LM-9300 Plus Lithotripter is LNS.

Related Devices (Code: LNS)

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.

K261086Break WaveSonomotion, Inc.K252913Break WaveSonomotion, Inc.K242922Extracorporeal Shock Wave Lithotripter (U200)Shenzhen Wikkon Precision Technologies Co., Ltd.K221903Delta III ProDornier Medtech America, Inc.K201001Modulith SLX-F2Karl Storz Endoscopy AmericaK201074Delta III LithotripterDornier Medtech America, Inc.

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.

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