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FDA 510(k)

OPTHALMIC SURGICAL INSTRUMENTS

K-Number: K860744 · 1986-03-31

ApplicantTridak Division of Indicon, Inc.
Decision Date1986-03-31
Product CodeHMX
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

OPTHALMIC SURGICAL INSTRUMENTS is the device name listed in this FDA 510(k) record. The listed applicant is Tridak Division of Indicon, Inc.. It received FDA 510(k) clearance on 1986-03-31 under 510(k) number K860744. 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 OPTHALMIC SURGICAL INSTRUMENTS?

OPTHALMIC SURGICAL INSTRUMENTS is a medical device that received FDA 510(k) clearance on 1986-03-31. The listed applicant is Tridak Division of Indicon, Inc.. The 510(k) number is K860744.

When did OPTHALMIC SURGICAL INSTRUMENTS receive FDA 510(k) clearance?

OPTHALMIC SURGICAL INSTRUMENTS received FDA 510(k) clearance on 1986-03-31, under 510(k) number K860744.

Who is the listed applicant for OPTHALMIC SURGICAL INSTRUMENTS?

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

What is the FDA product code for OPTHALMIC SURGICAL INSTRUMENTS?

The FDA product code for OPTHALMIC SURGICAL INSTRUMENTS is HMX.

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Other records listing Tridak Division of Indicon, 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.

K891007NONIMPLANTED ELECTRICAL CONTINENCE DEVICEK853059LABORIE FIBEROPTIC PRESSURE SENSOR & INTERFACEK852856LABORIE URODYNAMICS PROCESSORK851934CYTOLOGICAL CERVICAL SPATULA THE MULTI-SPATULAK842609R.L. MEDICAL TWIN LIGHT SOURCEK840605LABORIE FIBREOPTIC LIGHT CABLE

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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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