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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 the device name listed in this FDA 510(k) record. The listed applicant is Laborie Medical Technologies, Corp.. It received FDA 510(k) clearance on 2024-04-23 under 510(k) 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. The listed applicant is Laborie Medical Technologies, Corp.. The 510(k) number is K234107.

When did Solar™ Anorectal Manometry Catheter (Model Number: K1210AC-L-2212) receive FDA 510(k) clearance?

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

Who is the listed applicant for Solar™ Anorectal Manometry Catheter (Model Number: K1210AC-L-2212)?

The FDA 510(k) record lists Laborie Medical Technologies, Corp. as the applicant. This does not by itself establish the device manufacturer.

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

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.

NCT07367620Immediate Mechanical Complications After Central Venous CatheterizationCOMPLETEDNCT07789782Comparison of a New Non-invasive Device With the Current Invasive Gold-standard Investigation to Assess Movement and Function of the Large Bowel in ChildrenNOT_YET_RECRUITING

Other records listing Laborie Medical Technologies, Corp. 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.

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

Related Devices (Code: KLA)

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.

K242666Fecobionics Anorectal SystemGi Bionics, LLCK242304REDNeuraxis, Inc.K180135THD Anopress with THD SensyProbeThd SpaK161785THD ANOPRESSThd Spa

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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