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FDA 510(k)

IRRIGATION/ASPIRATION CANNULAS, VARIOUS SIZES

K-Number: K861545 · 1986-05-28

ApplicantRophae Lens Co., Inc.
Decision Date1986-05-28
Product CodeHMX
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

IRRIGATION/ASPIRATION CANNULAS, VARIOUS SIZES is the device name listed in this FDA 510(k) record. The listed applicant is Rophae Lens Co., Inc.. It received FDA 510(k) clearance on 1986-05-28 under 510(k) number K861545. The device is classified under product code HMX. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IRRIGATION/ASPIRATION CANNULAS, VARIOUS SIZES?

IRRIGATION/ASPIRATION CANNULAS, VARIOUS SIZES is a medical device that received FDA 510(k) clearance on 1986-05-28. The listed applicant is Rophae Lens Co., Inc.. The 510(k) number is K861545.

When did IRRIGATION/ASPIRATION CANNULAS, VARIOUS SIZES receive FDA 510(k) clearance?

IRRIGATION/ASPIRATION CANNULAS, VARIOUS SIZES received FDA 510(k) clearance on 1986-05-28, under 510(k) number K861545.

Who is the listed applicant for IRRIGATION/ASPIRATION CANNULAS, VARIOUS SIZES?

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

What is the FDA product code for IRRIGATION/ASPIRATION CANNULAS, VARIOUS SIZES?

The FDA product code for IRRIGATION/ASPIRATION CANNULAS, VARIOUS SIZES is HMX.

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 Rophae Lens Co., 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.

K861491ROPHAE DIAMOND KNIFE

Related Devices (Code: HMX)

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.

K010305WEISS RETINAL CANNULAMicron Surgical, Inc.K000457VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES; PHOTOFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 12000 SERIESRetinalabs.ComK970873ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.)American Medical Devices, Inc.K943932STERISEAL OPHTHALMIC CANNULAPharma-Plast, Ltd.K942403INFUSION CANNULAMicrosurgical Technology, Inc.K934844INTER TIP TMicrosurgical Technology, Inc.

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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