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)

SYNTEC TRUE LIGHT END IRRIGATING ENDOILLUMINATOR

K-Number: K973293 · 1997-11-18

ApplicantVaughan Weeks
Decision Date1997-11-18
Product CodeMPA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SYNTEC TRUE LIGHT END IRRIGATING ENDOILLUMINATOR is the device name listed in this FDA 510(k) record. The listed applicant is Vaughan Weeks. It received FDA 510(k) clearance on 1997-11-18 under 510(k) number K973293. The device is classified under product code MPA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNTEC TRUE LIGHT END IRRIGATING ENDOILLUMINATOR?

SYNTEC TRUE LIGHT END IRRIGATING ENDOILLUMINATOR is a medical device that received FDA 510(k) clearance on 1997-11-18. The listed applicant is Vaughan Weeks. The 510(k) number is K973293.

When did SYNTEC TRUE LIGHT END IRRIGATING ENDOILLUMINATOR receive FDA 510(k) clearance?

SYNTEC TRUE LIGHT END IRRIGATING ENDOILLUMINATOR received FDA 510(k) clearance on 1997-11-18, under 510(k) number K973293.

Who is the listed applicant for SYNTEC TRUE LIGHT END IRRIGATING ENDOILLUMINATOR?

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

What is the FDA product code for SYNTEC TRUE LIGHT END IRRIGATING ENDOILLUMINATOR?

The FDA product code for SYNTEC TRUE LIGHT END IRRIGATING ENDOILLUMINATOR is MPA.

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 Vaughan Weeks 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.

K973290SYNTEC TRUE LIGHT ENDOILLUMIINATOR WITH PICK

Related Devices (Code: MPA)

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.

K253468Nova Eye iTrack™ 250A Canaloplasty Microcatheter (iTrack™ 250A)Nova Eye, Inc.K242184Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256);Alcon Laboratories, Inc.K233653Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga (3269.M05-00); Midfield Light Pipe, 27ga (3269.M04-00)Peregrine Surgical, LLCK221872ITrack Advance Canaloplasty Microcatheter with Advanced Delivery SystemNova Eye Inc. (Business Name Nova Eye Medical)K202670Nam illumination probe with chopperOculight , Ltd.K080067ISCIENCE INTERVENTIONAL OPHTHALMIC MICROCATHETERIscience Interventional

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.

↑