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)

STERILE IRRIGATING SYRINGES, KITS,TRAY

K-Number: K813027 · 1981-11-20

ApplicantWelcon, Inc.
Decision Date1981-11-20
Product CodeKYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STERILE IRRIGATING SYRINGES, KITS,TRAY is the device name listed in this FDA 510(k) record. The listed applicant is Welcon, Inc.. It received FDA 510(k) clearance on 1981-11-20 under 510(k) number K813027. The device is classified under product code KYZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERILE IRRIGATING SYRINGES, KITS,TRAY?

STERILE IRRIGATING SYRINGES, KITS,TRAY is a medical device that received FDA 510(k) clearance on 1981-11-20. The listed applicant is Welcon, Inc.. The 510(k) number is K813027.

When did STERILE IRRIGATING SYRINGES, KITS,TRAY receive FDA 510(k) clearance?

STERILE IRRIGATING SYRINGES, KITS,TRAY received FDA 510(k) clearance on 1981-11-20, under 510(k) number K813027.

Who is the listed applicant for STERILE IRRIGATING SYRINGES, KITS,TRAY?

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

What is the FDA product code for STERILE IRRIGATING SYRINGES, KITS,TRAY?

The FDA product code for STERILE IRRIGATING SYRINGES, KITS,TRAY is KYZ.

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 Welcon, 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.

K003402WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FOR DEVICE IRRIGATIONK973734STERILE WATER FOR DEVICE IRRIGATION/ STERILE SALINE FOR DEVICE IRRIGATIONK971764WELCON HUE-VU URINARY DRAINAGE BAGK912869WOMEN AND INFANT'S DELIVERY PACKK904158ACCORDE(R) IRRIGATING SYRINGE/PROCEDURE TRAYK894397WELCON LIGHT HANDLE

View all 8 devices →

Related Devices (Code: KYZ)

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.

K201877OtoSet- Ear Cleaning SystemSafkan, Inc.K102563SINGLE CANNULA EXTENDED APPLICATORMicromedics, Inc.K092022TISSU TRANS HARVEST TUBINGShippert Medical Technologies Corp.K050797TISSU-TRANSShippert Medical Technologies Corp.K991254QS DELIVERY SYSTEMSub-Q, Inc.K982435IRRIGATION SYRINGE KITSub-Q, 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.

↑