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)

ROLLER KNIFE-TRANSVERSE -SAGITTAL

K-Number: K833602 · 1984-01-03

ApplicantMicrotek Medical, Inc.
Decision Date1984-01-03
Product CodeJYO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ROLLER KNIFE-TRANSVERSE -SAGITTAL is the device name listed in this FDA 510(k) record. The listed applicant is Microtek Medical, Inc.. It received FDA 510(k) clearance on 1984-01-03 under 510(k) number K833602. 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 ROLLER KNIFE-TRANSVERSE -SAGITTAL?

ROLLER KNIFE-TRANSVERSE -SAGITTAL is a medical device that received FDA 510(k) clearance on 1984-01-03. The listed applicant is Microtek Medical, Inc.. The 510(k) number is K833602.

When did ROLLER KNIFE-TRANSVERSE -SAGITTAL receive FDA 510(k) clearance?

ROLLER KNIFE-TRANSVERSE -SAGITTAL received FDA 510(k) clearance on 1984-01-03, under 510(k) number K833602.

Who is the listed applicant for ROLLER KNIFE-TRANSVERSE -SAGITTAL?

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

What is the FDA product code for ROLLER KNIFE-TRANSVERSE -SAGITTAL?

The FDA product code for ROLLER KNIFE-TRANSVERSE -SAGITTAL 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 Microtek 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.

K110358VENODYNE V810K102971FREEDOMAIRE III SURGICAL HELMET SYSTEM MODEL 10322STKK062899MICROTEK MEDICAL SURGICAL GOWN/TOGAK060200MICROTEK MEDICAL WARMING DRAPEK050322MICROTEK EQUIPMENT DRAPESK022903CHILLBUSTER

View all 24 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.K823911KNIFE BLADE TIPTreace Medical, Inc.K772372ROLLER KNIFEEdward Weck, Inc.K772384MYRINGOTOMY 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.

↑