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FDA 510(k)

MOLTENO IMPLANT

K-Number: K890598 · 1989-02-27

ApplicantIop, Inc.
Decision Date1989-02-27
Product CodeKYF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MOLTENO IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Iop, Inc.. It received FDA 510(k) clearance on 1989-02-27 under 510(k) number K890598. The device is classified under product code KYF. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MOLTENO IMPLANT?

MOLTENO IMPLANT is a medical device that received FDA 510(k) clearance on 1989-02-27. The listed applicant is Iop, Inc.. The 510(k) number is K890598.

When did MOLTENO IMPLANT receive FDA 510(k) clearance?

MOLTENO IMPLANT received FDA 510(k) clearance on 1989-02-27, under 510(k) number K890598.

Who is the listed applicant for MOLTENO IMPLANT?

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

What is the FDA product code for MOLTENO IMPLANT?

The FDA product code for MOLTENO IMPLANT is KYF.

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Other records listing Iop, 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.

K090078KERASYS BIOENGINEERED LAMELLAR PATCH GRAFTK062252MOLTENO3K053622SURGISIS OCULAR GRAFTK010852OSMED TISSUE EXPANDERK003646SUTUREGROOVE WEIGHT SIZING SETK994289SUTUREGROOVE

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Related Devices (Code: KYF)

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.

K230975Ahmed® Glaucoma Valve Model FP7New World Medical, Inc.K231051Ahmed® Glaucoma Valve Model FP8New World Medical, Inc.K220032iStent infinite Trabecular Micro-Bypass System, Model iS3Glaukos CorporationK182518AHMED ClearPath Glaucoma Drainage DeviceNew World Medical, Inc.K171451Ahmed Glaucoma Valve Model FP8New World Medical, Inc.K161457XEN Glaucoma Treatment SystemAllergan, 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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