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FDA 510(k)

KRUPIN EYE VALVE W/SCLERAL BUCKLE

K-Number: K885125 · 1989-01-24

ApplicantHood Laboratories
Decision Date1989-01-24
Product CodeKYF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

KRUPIN EYE VALVE W/SCLERAL BUCKLE is the device name listed in this FDA 510(k) record. The listed applicant is Hood Laboratories. It received FDA 510(k) clearance on 1989-01-24 under 510(k) number K885125. 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 KRUPIN EYE VALVE W/SCLERAL BUCKLE?

KRUPIN EYE VALVE W/SCLERAL BUCKLE is a medical device that received FDA 510(k) clearance on 1989-01-24. The listed applicant is Hood Laboratories. The 510(k) number is K885125.

When did KRUPIN EYE VALVE W/SCLERAL BUCKLE receive FDA 510(k) clearance?

KRUPIN EYE VALVE W/SCLERAL BUCKLE received FDA 510(k) clearance on 1989-01-24, under 510(k) number K885125.

Who is the listed applicant for KRUPIN EYE VALVE W/SCLERAL BUCKLE?

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

What is the FDA product code for KRUPIN EYE VALVE W/SCLERAL BUCKLE?

The FDA product code for KRUPIN EYE VALVE W/SCLERAL BUCKLE is KYF.

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Other records listing Hood Laboratories 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.

K921452ACOUSTIC RHINOMETERK920994HOOD NASAL SEPTAL BUTTONK905703KRUPIN EYE VALVE WITH DISKK904821ELIACHAR MODIFIED ESOPHAGEAL STENTK897049GIBSON ENDOLYMPHATIC SHUNTK897059HOOD SPEAKING VALVE

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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.

K231051Ahmed® Glaucoma Valve Model FP8New World Medical, Inc.K230975Ahmed® Glaucoma Valve Model FP7New 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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