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)

OCULAR IRRIGATING CANNULA

K-Number: K831532 · 1983-07-12

ApplicantDey Laboratories, Inc.
Decision Date1983-07-12
Product CodeHMX
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

OCULAR IRRIGATING CANNULA is the device name listed in this FDA 510(k) record. The listed applicant is Dey Laboratories, Inc.. It received FDA 510(k) clearance on 1983-07-12 under 510(k) number K831532. The device is classified under product code HMX. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OCULAR IRRIGATING CANNULA?

OCULAR IRRIGATING CANNULA is a medical device that received FDA 510(k) clearance on 1983-07-12. The listed applicant is Dey Laboratories, Inc.. The 510(k) number is K831532.

When did OCULAR IRRIGATING CANNULA receive FDA 510(k) clearance?

OCULAR IRRIGATING CANNULA received FDA 510(k) clearance on 1983-07-12, under 510(k) number K831532.

Who is the listed applicant for OCULAR IRRIGATING CANNULA?

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

What is the FDA product code for OCULAR IRRIGATING CANNULA?

The FDA product code for OCULAR IRRIGATING CANNULA is HMX.

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 Dey Laboratories, 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.

K972778DEY VIAL SODIUM CHLORIDE 3%K910239NEBU-SOL METERED DOSE DISPENSER (TM)K880411DEY-VIAL SODIUM CHLORIDE SOLUTION, USP, STERILEK875011DEY-PAK PURIFIED WATER, USP, STERILEK875024DEY-PAK AND DEY-VIAL SODIUM CHLORIDE SOLUTION, USP

Related Devices (Code: HMX)

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.

K010305WEISS RETINAL CANNULAMicron Surgical, Inc.K000457VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES; PHOTOFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 12000 SERIESRetinalabs.ComK970873ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.)American Medical Devices, Inc.K943932STERISEAL OPHTHALMIC CANNULAPharma-Plast, Ltd.K942403INFUSION CANNULAMicrosurgical Technology, Inc.K934844INTER TIP TMicrosurgical Technology, Inc.

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.

↑