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FDA 510(k)

OCUCARE ULTRASOUND TIP & FREEDOM PACK

K-Number: K834543 · 1984-03-16

ApplicantIntermedics Intraocular, Inc.
Decision Date1984-03-16
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

OCUCARE ULTRASOUND TIP & FREEDOM PACK is the device name listed in this FDA 510(k) record. The listed applicant is Intermedics Intraocular, Inc.. It received FDA 510(k) clearance on 1984-03-16 under 510(k) number K834543. 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 OCUCARE ULTRASOUND TIP & FREEDOM PACK?

OCUCARE ULTRASOUND TIP & FREEDOM PACK is a medical device that received FDA 510(k) clearance on 1984-03-16. The listed applicant is Intermedics Intraocular, Inc.. The 510(k) number is K834543.

When did OCUCARE ULTRASOUND TIP & FREEDOM PACK receive FDA 510(k) clearance?

OCUCARE ULTRASOUND TIP & FREEDOM PACK received FDA 510(k) clearance on 1984-03-16, under 510(k) number K834543.

Who is the listed applicant for OCUCARE ULTRASOUND TIP & FREEDOM PACK?

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

What is the FDA product code for OCUCARE ULTRASOUND TIP & FREEDOM PACK?

The FDA product code for OCUCARE ULTRASOUND TIP & FREEDOM 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.

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Other records listing Intermedics Intraocular, 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.

K862070INTER-SHARPK841730BAILEY LENS SHOOTERK832525IRRIGATION/ASPIRATION PACK

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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