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

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 a medical device manufactured by Lite-Med, Inc.. It received FDA 510(k) clearance on 2023-01-19 under approval 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. It is manufactured by Lite-Med, Inc.. The 510(k) number is K213772.

When was LM-9300 Plus Lithotripter approved by the FDA?

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

What company makes LM-9300 Plus Lithotripter?

LM-9300 Plus Lithotripter is manufactured by Lite-Med, Inc..

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)

K172084Delta III LithotripterDornier Medtech America, Inc. K170122Delta III LithotripterDornier Medtech America K201074Delta III LithotripterDornier Medtech America, Inc. K201001Modulith SLX-F2Karl Storz Endoscopy America K221903Delta III ProDornier Medtech America, Inc. K242922Extracorporeal Shock Wave Lithotripter (U200)Shenzhen Wikkon Precision Technologies Co., Ltd.

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.

↑