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FDA 510(k)

OSHER SURGICAL GONIO/POSTERIOR POLE LENS

K-Number: K935302 · 1994-04-01

ApplicantOcular Instruments, Inc.
Decision Date1994-04-01
Product CodeHKS
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

OSHER SURGICAL GONIO/POSTERIOR POLE LENS is the device name listed in this FDA 510(k) record. The listed applicant is Ocular Instruments, Inc.. It received FDA 510(k) clearance on 1994-04-01 under 510(k) number K935302. The device is classified under product code HKS. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSHER SURGICAL GONIO/POSTERIOR POLE LENS?

OSHER SURGICAL GONIO/POSTERIOR POLE LENS is a medical device that received FDA 510(k) clearance on 1994-04-01. The listed applicant is Ocular Instruments, Inc.. The 510(k) number is K935302.

When did OSHER SURGICAL GONIO/POSTERIOR POLE LENS receive FDA 510(k) clearance?

OSHER SURGICAL GONIO/POSTERIOR POLE LENS received FDA 510(k) clearance on 1994-04-01, under 510(k) number K935302.

Who is the listed applicant for OSHER SURGICAL GONIO/POSTERIOR POLE LENS?

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

What is the FDA product code for OSHER SURGICAL GONIO/POSTERIOR POLE LENS?

The FDA product code for OSHER SURGICAL GONIO/POSTERIOR POLE LENS is HKS.

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Other records listing Ocular Instruments, 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.

K014170STAURENGHI WIDE FIELD SCANNING LASER LENSK012096DISPOSABLE VITRECTOMY LENSK933976MANDELKORN SUTURE LYSIS LENSK933264RITCH NYLON SUTURE LASER LENSK94142050 DEGREE HRI PRISM LENSK923670BYRNE EXPULSIVE LENS

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Related Devices (Code: HKS)

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.

K895846TWO MIRROR GONIO LENSOcular Instruments, Inc.K890977MCINTYRE SURGICAL GONIOLENSOcular Instruments, Inc.K862713ABRAHAM IRIDECTOMY LENS (YAG LASER)Ocular Instruments, Inc.K862692KARICKHOFF DIAGNOSTIC/LASER LENSOcular Instruments, Inc.K862024SUSSMAN FOUR MIRROR HAND HELD GONIOPRISMOcular Instruments, Inc.K862512RITCH TRABECULOPLASTY LASER LENSOcular Instruments, 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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