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)

CAVITRON/KELMAN PHACOEMULSIFIER ASPIRATOR, UNIV.

K-Number: K890635 · 1989-05-09

ApplicantCooperVision, Inc.
Decision Date1989-05-09
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

CAVITRON/KELMAN PHACOEMULSIFIER ASPIRATOR, UNIV. is the device name listed in this FDA 510(k) record. The listed applicant is CooperVision, Inc.. It received FDA 510(k) clearance on 1989-05-09 under 510(k) number K890635. 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 CAVITRON/KELMAN PHACOEMULSIFIER ASPIRATOR, UNIV.?

CAVITRON/KELMAN PHACOEMULSIFIER ASPIRATOR, UNIV. is a medical device that received FDA 510(k) clearance on 1989-05-09. The listed applicant is CooperVision, Inc.. The 510(k) number is K890635.

When did CAVITRON/KELMAN PHACOEMULSIFIER ASPIRATOR, UNIV. receive FDA 510(k) clearance?

CAVITRON/KELMAN PHACOEMULSIFIER ASPIRATOR, UNIV. received FDA 510(k) clearance on 1989-05-09, under 510(k) number K890635.

Who is the listed applicant for CAVITRON/KELMAN PHACOEMULSIFIER ASPIRATOR, UNIV.?

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

What is the FDA product code for CAVITRON/KELMAN PHACOEMULSIFIER ASPIRATOR, UNIV.?

The FDA product code for CAVITRON/KELMAN PHACOEMULSIFIER ASPIRATOR, UNIV. 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 CooperVision, 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.

K234127Clariti 1 day Multifocal (somofilcon A) Soft (Hydrophilic), Daily Disposable Contact Lens with UV BlockerK220070MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality (fanfilcon A) Soft (Hydrophilic) Contact LensK213164Avaira VitalityK202756Clariti 1 Day (somofilcon A), Clariti 1 Day Toric (somofilcon A), Clariti 1 Day Multifocal (somofilcon A), Clariti 1 Day Multifocal Toric (somofilcon A)K191763MyDay (Stenfilcon A) ASPHERE, MyDay (Stenfilcon A) TORIC, MyDay (Stenfilcon A) MULTIFOCAL, MyDay (Stenfilcon A) MULTIFOCAL TORICK190965MyDay

View all 97 devices →

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

View on FDA Database →

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

↑