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)

MYRINGOTOMY KNIFE

K-Number: K772384 · 1978-01-17

ApplicantEdward Weck, Inc.
Decision Date1978-01-17
Product CodeJYO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MYRINGOTOMY KNIFE is the device name listed in this FDA 510(k) record. The listed applicant is Edward Weck, Inc.. It received FDA 510(k) clearance on 1978-01-17 under 510(k) number K772384. The device is classified under product code JYO. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MYRINGOTOMY KNIFE?

MYRINGOTOMY KNIFE is a medical device that received FDA 510(k) clearance on 1978-01-17. The listed applicant is Edward Weck, Inc.. The 510(k) number is K772384.

When did MYRINGOTOMY KNIFE receive FDA 510(k) clearance?

MYRINGOTOMY KNIFE received FDA 510(k) clearance on 1978-01-17, under 510(k) number K772384.

Who is the listed applicant for MYRINGOTOMY KNIFE?

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

What is the FDA product code for MYRINGOTOMY KNIFE?

The FDA product code for MYRINGOTOMY KNIFE is JYO.

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 Edward Weck, 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.

K915378WECK TROCARK914690LM15(TM), CATALOG NUMBER - 523821K911915HEMOCLIP IIK914470PNEUMO-SEAL(TM)K911272ENDOSCOPIC NEEDLHOLDER CAT. NUMBER 114705K902108HEM-O-LOK(TM)

View all 140 devices →

Related Devices (Code: JYO)

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.

K910212COLOR DOPPLER OPTION TO AI 5200 DIAG ULTRASO SYSTAcoustic Imaging Technologies Corp.K841006EAR KNIFE-VARIOUSPremier Dental Products Co.K840764EAR KNIVESSharpoint, Inc.K833602ROLLER KNIFE-TRANSVERSE -SAGITTALMicrotek Medical, Inc.K823911KNIFE BLADE TIPTreace Medical, Inc.K772372ROLLER KNIFEEdward Weck, 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.

↑