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FDA 510(k)

KOI LACRIMAL INTUBATION SYSTEM

K-Number: K812010 · 1981-07-28

ApplicantKoi, Inc.
Decision Date1981-07-28
Product CodeHMX
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

KOI LACRIMAL INTUBATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Koi, Inc.. It received FDA 510(k) clearance on 1981-07-28 under 510(k) number K812010. 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 KOI LACRIMAL INTUBATION SYSTEM?

KOI LACRIMAL INTUBATION SYSTEM is a medical device that received FDA 510(k) clearance on 1981-07-28. The listed applicant is Koi, Inc.. The 510(k) number is K812010.

When did KOI LACRIMAL INTUBATION SYSTEM receive FDA 510(k) clearance?

KOI LACRIMAL INTUBATION SYSTEM received FDA 510(k) clearance on 1981-07-28, under 510(k) number K812010.

Who is the listed applicant for KOI LACRIMAL INTUBATION SYSTEM?

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

What is the FDA product code for KOI LACRIMAL INTUBATION SYSTEM?

The FDA product code for KOI LACRIMAL INTUBATION SYSTEM 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 Koi, 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.

K843247KOI PACHYMETERK830366DIAMOND KNIFEK812764KOI BLUE FIELD ENTOPTOSCOPEK812450KOI DIAMOND KNIFEK812097KOI LACREMAL HOOK & DILATORK812011BLADE GAUGE

View all 7 devices →

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

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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