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FDA 510(k)

MANUAL SURGICAL INSTRUMENTS FOR TITAMED ANTWERP

K-Number: K896589 · 1989-12-27

ApplicantOptik
Decision Date1989-12-27
Product CodeLRZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MANUAL SURGICAL INSTRUMENTS FOR TITAMED ANTWERP is the device name listed in this FDA 510(k) record. The listed applicant is Optik. It received FDA 510(k) clearance on 1989-12-27 under 510(k) number K896589. The device is classified under product code LRZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MANUAL SURGICAL INSTRUMENTS FOR TITAMED ANTWERP?

MANUAL SURGICAL INSTRUMENTS FOR TITAMED ANTWERP is a medical device that received FDA 510(k) clearance on 1989-12-27. The listed applicant is Optik. The 510(k) number is K896589.

When did MANUAL SURGICAL INSTRUMENTS FOR TITAMED ANTWERP receive FDA 510(k) clearance?

MANUAL SURGICAL INSTRUMENTS FOR TITAMED ANTWERP received FDA 510(k) clearance on 1989-12-27, under 510(k) number K896589.

Who is the listed applicant for MANUAL SURGICAL INSTRUMENTS FOR TITAMED ANTWERP?

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

What is the FDA product code for MANUAL SURGICAL INSTRUMENTS FOR TITAMED ANTWERP?

The FDA product code for MANUAL SURGICAL INSTRUMENTS FOR TITAMED ANTWERP is LRZ.

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 Optik 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.

K933776OPTIK LAPAROSCOPEK926166COAST VIDEO ENDOSCOPIC IMAGING SYSTEMK896404TITAMED ANTWERP SYSTEMK894558MINI LIGHTSCOPE SET, LIGHTSCOPE JR. SETK894557LIGHTSCOPE SET

Related Devices (Code: LRZ)

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.

K8724901.1 SCREWDRIVERSMicro-Aire Surgical Instruments, Inc.K872387STANDARD SCREW DRIVERMed-Tool, 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.

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