FDA 510(k)

Solar Anorectal Manometry Catheter (Model Number: K1210AC-L-2212)

K-Number: K234107 · 2024-04-23

ApplicantLaborie Medical Technologies, Corp.

Decision Date2024-04-23

Product CodeKLA

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Solar Anorectal Manometry Catheter (Model Number: K1210AC-L-2212) is a medical device manufactured by Laborie Medical Technologies, Corp.. It received FDA 510(k) clearance on 2024-04-23 under approval number K234107. The device is classified under product code KLA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Solar Anorectal Manometry Catheter (Model Number: K1210AC-L-2212)?

Solar Anorectal Manometry Catheter (Model Number: K1210AC-L-2212) is a medical device that received FDA 510(k) clearance on 2024-04-23. It is manufactured by Laborie Medical Technologies, Corp.. The 510(k) number is K234107.

When was Solar Anorectal Manometry Catheter (Model Number: K1210AC-L-2212) approved by the FDA?

Solar Anorectal Manometry Catheter (Model Number: K1210AC-L-2212) received FDA 510(k) clearance on 2024-04-23, under approval number K234107.

What company makes Solar Anorectal Manometry Catheter (Model Number: K1210AC-L-2212)?

Solar Anorectal Manometry Catheter (Model Number: K1210AC-L-2212) is manufactured by Laborie Medical Technologies, Corp..

What is the FDA product code for Solar Anorectal Manometry Catheter (Model Number: K1210AC-L-2212)?

The FDA product code for Solar Anorectal Manometry Catheter (Model Number: K1210AC-L-2212) is KLA.

Related Clinical Trials

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Related PubMed Literature

PMID: 41915420 Analysis Model for Infant Incubator Adverse Events Using Retrieval-Augmented Generation Combined With Dual-Adapter Fine-Tuning: Development and Evaluation Study. JMIR medical informatics (2026)

Other Devices by Laborie Medical Technologies, Corp.

K241523injeTAK Adjustable Tip Needle (DIS199; DIS201) K240007Solar Compact (G4-1)

Related Devices (Code: KLA)

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Official Source

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