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)

LACRICATH LACRIMAL DUCT CATHETER

K-Number: K113867 · 2012-10-19

ApplicantQuest Medical, Inc.
Decision Date2012-10-19
Product CodeOKS
DecisionSubstantially Equivalent

Device Summary

LACRICATH LACRIMAL DUCT CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Quest Medical, Inc.. It received FDA 510(k) clearance on 2012-10-19 under 510(k) number K113867. The device is classified under product code OKS. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LACRICATH LACRIMAL DUCT CATHETER?

LACRICATH LACRIMAL DUCT CATHETER is a medical device that received FDA 510(k) clearance on 2012-10-19. The listed applicant is Quest Medical, Inc.. The 510(k) number is K113867.

When did LACRICATH LACRIMAL DUCT CATHETER receive FDA 510(k) clearance?

LACRICATH LACRIMAL DUCT CATHETER received FDA 510(k) clearance on 2012-10-19, under 510(k) number K113867.

Who is the listed applicant for LACRICATH LACRIMAL DUCT CATHETER?

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

What is the FDA product code for LACRICATH LACRIMAL DUCT CATHETER?

The FDA product code for LACRICATH LACRIMAL DUCT CATHETER is OKS.

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 Quest Medical, Inc. 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.

K241058Lyka® PORT Needle Free Access Device (4170Y)K213846Q2 Blood Administration SetsK213588Q2 IV Administration SetsK202672Precision Delivery Infusion SetK201984MPS 3 ND Myocardial Protection SystemK200438MPS 3 Myocardial Protection System

View all 38 devices →

Related Devices (Code: OKS)

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.

K201892Ritleng®+ and Ritleng®+ PVPFci (France Chirurgie Instrumentation) SasK201606LacriJet®Fci (France Chirurgie Instrumentation) SasK170247Lacriflow CLKaneka Pharma America, LLCK161373NunchakuFci (France Chirurgie Instrumentation)K160710Oasis Lacrimal Intubation SetAnodyneK130375SELF-RETAINING BICANALICULUS INTUBATON SET IIFci Sas (France Chirurgie Instrumentation)

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.

↑