FDA 510(k)

IOCARE IRRIGATION/ASPIRATION PACK

K-Number: K843275 · 1984-11-27

Decision Date1984-11-27

Product CodeHQC

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

IOCARE IRRIGATION/ASPIRATION PACK is the device name listed in this FDA 510(k) record. The listed applicant is Chiron Vision Corp.. It received FDA 510(k) clearance on 1984-11-27 under 510(k) number K843275. 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 IOCARE IRRIGATION/ASPIRATION PACK?

IOCARE IRRIGATION/ASPIRATION PACK is a medical device that received FDA 510(k) clearance on 1984-11-27. The listed applicant is Chiron Vision Corp.. The 510(k) number is K843275.

When did IOCARE IRRIGATION/ASPIRATION PACK receive FDA 510(k) clearance?

IOCARE IRRIGATION/ASPIRATION PACK received FDA 510(k) clearance on 1984-11-27, under 510(k) number K843275.

Who is the listed applicant for IOCARE IRRIGATION/ASPIRATION PACK?

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

What is the FDA product code for IOCARE IRRIGATION/ASPIRATION PACK?

The FDA product code for IOCARE IRRIGATION/ASPIRATION PACK 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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Chiron Vision Corp. as applicant

K970727MPORT FOLDABLE LENS PLACEMENT SYSTEM K972808HANSATOME MICROKERATOME K960414SYNERGIST POWER PACK K944993IOLAB.SITE CD PHACOEMULSIFICATION MODULE K944995IOLAB/SITE PERISTALTIC MODULE K951292PASSPORT FOLDABLE LENS PLACEMENT SYSTEM

View all 34 devices →

Related Devices (Code: HQC)

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 Lomb K252052Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E)Bausch and Lomb, Incorporated K250501System SophiThis AG K243395MICOR 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.