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)

MICROTEK SEPTAL BUTTON

K-Number: K862497 · 1986-07-14

ApplicantMicrotek Medical, Inc.
Decision Date1986-07-14
Product CodeLFB
DecisionSubstantially Equivalent

Device Summary

MICROTEK SEPTAL BUTTON 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 1986-07-14 under 510(k) number K862497. The device is classified under product code LFB. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROTEK SEPTAL BUTTON?

MICROTEK SEPTAL BUTTON is a medical device that received FDA 510(k) clearance on 1986-07-14. The listed applicant is Microtek Medical, Inc.. The 510(k) number is K862497.

When did MICROTEK SEPTAL BUTTON receive FDA 510(k) clearance?

MICROTEK SEPTAL BUTTON received FDA 510(k) clearance on 1986-07-14, under 510(k) number K862497.

Who is the listed applicant for MICROTEK SEPTAL BUTTON?

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 MICROTEK SEPTAL BUTTON?

The FDA product code for MICROTEK SEPTAL BUTTON is LFB.

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: LFB)

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.

K131745BLOM-SINGER SEPTAL PERFORATION PROSTHESISHelix Medical, LLCK013696SILMED NASAL SEPTAL BUTTONSilmed, Inc.K982667MICROMEDICS NASAL SEPTAL BUTTONMicromedics, Inc.K972060NASAL SEPTAL BUTTONBoston Medical Products, Inc.K920994HOOD NASAL SEPTAL BUTTONHood LaboratoriesK901366INVOTEC SEPTAL BUTTONInvotec International, 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.

↑