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

FDA 510(k)

FLEXILOG LS 13921

K-Number: K961895 · 1996-11-04

ApplicantOakfield Instruments, Ltd.
Decision Date1996-11-04
Product CodeKLA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FLEXILOG LS 13921 is the device name listed in this FDA 510(k) record. The listed applicant is Oakfield Instruments, Ltd.. It received FDA 510(k) clearance on 1996-11-04 under 510(k) number K961895. 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 FLEXILOG LS 13921?

FLEXILOG LS 13921 is a medical device that received FDA 510(k) clearance on 1996-11-04. The listed applicant is Oakfield Instruments, Ltd.. The 510(k) number is K961895.

When did FLEXILOG LS 13921 receive FDA 510(k) clearance?

FLEXILOG LS 13921 received FDA 510(k) clearance on 1996-11-04, under 510(k) number K961895.

Who is the listed applicant for FLEXILOG LS 13921?

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

What is the FDA product code for FLEXILOG LS 13921?

The FDA product code for FLEXILOG LS 13921 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Oakfield Instruments, Ltd. 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.

K964804FLEXILOG LSK964589FLEXILOG 3000K945069FLEXILOG 2000K920115MEDISCINTK902460CARDIOSCINT (LEFT VENTRICULAR FUNCTION MONITOR)K896288FLEXILOG 1010 AMBULATORY PH MONITORING SYSTEM

View all 8 devices →

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.K234107Solar™ Anorectal Manometry Catheter (Model Number: K1210AC-L-2212)Laborie Medical Technologies, Corp.K180135THD Anopress with THD SensyProbeThd SpaK161785THD ANOPRESSThd SpaK120088MCOMPASS ANORECTAL MANOMETRY SYSTEMMedspira, LLC

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.

↑