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FDA 510(k)

PHACOTRON DAY PAK

K-Number: K870671 · 1987-04-06

ApplicantUnited Surgical Corp.
Decision Date1987-04-06
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

PHACOTRON DAY PAK is the device name listed in this FDA 510(k) record. The listed applicant is United Surgical Corp.. It received FDA 510(k) clearance on 1987-04-06 under 510(k) number K870671. 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 PHACOTRON DAY PAK?

PHACOTRON DAY PAK is a medical device that received FDA 510(k) clearance on 1987-04-06. The listed applicant is United Surgical Corp.. The 510(k) number is K870671.

When did PHACOTRON DAY PAK receive FDA 510(k) clearance?

PHACOTRON DAY PAK received FDA 510(k) clearance on 1987-04-06, under 510(k) number K870671.

Who is the listed applicant for PHACOTRON DAY PAK?

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

What is the FDA product code for PHACOTRON DAY PAK?

The FDA product code for PHACOTRON DAY PAK is HQC.

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Other records listing United Surgical 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.

K902150PIEZO HANDPIECEK870806NON-STERILE, EXTRA PLUS PAK CAT. #USPK 2100K870194UNITED SURGICAL CORP. DIATHERMIC PLUSK870195UNITED SURGICAL CORP. CRYOPTIC PLUSK860014SYSTEMS PLUSK830741PARAMETRIC STERILITY RELEASE OF AUTO

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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.

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