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)

MANOMETRIC ASSEMBLIES

K-Number: K983665 · 1999-05-17

ApplicantDentsleeve Pty., Ltd.
Decision Date1999-05-17
Product CodeKLA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MANOMETRIC ASSEMBLIES is the device name listed in this FDA 510(k) record. The listed applicant is Dentsleeve Pty., Ltd.. It received FDA 510(k) clearance on 1999-05-17 under 510(k) number K983665. 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 MANOMETRIC ASSEMBLIES?

MANOMETRIC ASSEMBLIES is a medical device that received FDA 510(k) clearance on 1999-05-17. The listed applicant is Dentsleeve Pty., Ltd.. The 510(k) number is K983665.

When did MANOMETRIC ASSEMBLIES receive FDA 510(k) clearance?

MANOMETRIC ASSEMBLIES received FDA 510(k) clearance on 1999-05-17, under 510(k) number K983665.

Who is the listed applicant for MANOMETRIC ASSEMBLIES?

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

What is the FDA product code for MANOMETRIC ASSEMBLIES?

The FDA product code for MANOMETRIC ASSEMBLIES 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 Dentsleeve Pty., 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.

K013154MARK II/MARK III MANOMETRIC PERFUSION PUMPK980946MARK II CO2 FLUSH MANOMETRIC PERFUSION PUMP & MARK II MANOMETRIC PERFUSION PUMP

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.

↑