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FDA 510(k)

IRRI-EVACUATOR

K-Number: K895757 · 1989-10-19

ApplicantMikro-Tek Laboratories
Decision Date1989-10-19
Product CodeGBX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

IRRI-EVACUATOR is the device name listed in this FDA 510(k) record. The listed applicant is Mikro-Tek Laboratories. It received FDA 510(k) clearance on 1989-10-19 under 510(k) number K895757. The device is classified under product code GBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IRRI-EVACUATOR?

IRRI-EVACUATOR is a medical device that received FDA 510(k) clearance on 1989-10-19. The listed applicant is Mikro-Tek Laboratories. The 510(k) number is K895757.

When did IRRI-EVACUATOR receive FDA 510(k) clearance?

IRRI-EVACUATOR received FDA 510(k) clearance on 1989-10-19, under 510(k) number K895757.

Who is the listed applicant for IRRI-EVACUATOR?

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

What is the FDA product code for IRRI-EVACUATOR?

The FDA product code for IRRI-EVACUATOR is GBX.

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 Mikro-Tek Laboratories 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.

K895756MIKRO-AQUAPURATORK895755MIKRO-LAVAGE-1

Related Devices (Code: GBX)

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.

K082725GRAFTGUARD PRESSURE CONTROLLING SYRINGEMaquet Cardiovascular, LLCK052286DEUTSCH ANTI-BLOCKAGE WOUND DRAINThe Catheter Exchange, Inc.K043515GRAFTSAVERVescare, Inc.K013417MISONIX IRRIGATION SYSTEM MOEDL BC20PMisonix, Inc.K000704DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS)Dmc Medical, Ltd.K974233LYSONIX IRRIGATION SYSTEMLysonix, 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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