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)

TIK EXTRAKTOR

K-Number: K895212 · 1989-09-27

ApplicantInstruments of Sweden, Inc.
Decision Date1989-09-27
Product CodeHTD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TIK EXTRAKTOR is the device name listed in this FDA 510(k) record. The listed applicant is Instruments of Sweden, Inc.. It received FDA 510(k) clearance on 1989-09-27 under 510(k) number K895212. The device is classified under product code HTD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TIK EXTRAKTOR?

TIK EXTRAKTOR is a medical device that received FDA 510(k) clearance on 1989-09-27. The listed applicant is Instruments of Sweden, Inc.. The 510(k) number is K895212.

When did TIK EXTRAKTOR receive FDA 510(k) clearance?

TIK EXTRAKTOR received FDA 510(k) clearance on 1989-09-27, under 510(k) number K895212.

Who is the listed applicant for TIK EXTRAKTOR?

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

What is the FDA product code for TIK EXTRAKTOR?

The FDA product code for TIK EXTRAKTOR is HTD.

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

Related Devices (Code: HTD)

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.

K051281THE NEEDLE CATCHERE.D.Medical , Ltd.K974595CUSHING BAYONET, INSULATED BIPOLAR FORCEPTitan Mfg., Inc.K974593SEMKIN INSULATED BIPOLAR FORCEPTitan Mfg., Inc.K974594SEMKIN BIPOLAR FORCEPTitan Mfg., Inc.K913964MARLOW/REDDICK LAPAROSCOPIC GRASPING FORCEPSMarlo Surgical TechnologyK911180CLAW (5MM/10MM) ATRAUMATIC GRASP/MICRO FORCEPSNorthgate Technologies, 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.

↑