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FDA 510(k)

CATAREX/ULTRASONICS KIT

K-Number: K840181 · 1984-10-05

ApplicantCalliope Corp.
Decision Date1984-10-05
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

CATAREX/ULTRASONICS KIT is the device name listed in this FDA 510(k) record. The listed applicant is Calliope Corp.. It received FDA 510(k) clearance on 1984-10-05 under 510(k) number K840181. The device is classified under product code HQC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CATAREX/ULTRASONICS KIT?

CATAREX/ULTRASONICS KIT is a medical device that received FDA 510(k) clearance on 1984-10-05. The listed applicant is Calliope Corp.. The 510(k) number is K840181.

When did CATAREX/ULTRASONICS KIT receive FDA 510(k) clearance?

CATAREX/ULTRASONICS KIT received FDA 510(k) clearance on 1984-10-05, under 510(k) number K840181.

Who is the listed applicant for CATAREX/ULTRASONICS KIT?

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

What is the FDA product code for CATAREX/ULTRASONICS KIT?

The FDA product code for CATAREX/ULTRASONICS KIT is HQC.

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 Calliope Corp. 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.

K840063CATAREX VITRECUTTER I/A DISPOS. CUTK832446CATAREX DIAP. EXTRACAPSULAR CATARACT

Related Devices (Code: HQC)

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.

K261264Stellaris Elite™ vision enhancement system; Posterior and Combined Procedure Pack(s): 23 ga. Posterior Elite™ Pack (SE5423); 23 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5423B); 25 ga. Posterior Elite™ Pack (SE5425); 25 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5425B); 27 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5427B); 23 ga. Bi-Blade™+ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5423BB+); 25 ga. Bi-Blade™+Bausch and LombK252052Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E)Bausch and Lomb, IncorporatedK250501System SophiThis AGK243395MICOR 700 with Auto I/ACarl Zeiss Meditec Cataract Technology, Inc.K242801MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185)Carl Zeiss Meditec Cataract Technology, Inc.K240169Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455)Bausch and Lomb, Incorporated

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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