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FDA 510(k)

OPHTHALMIC KNIFE W/REMOVALE DEPTH GUIDE

K-Number: K853598 · 1985-11-04

ApplicantMyocure, Inc.
Decision Date1985-11-04
Product CodeHNN
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

OPHTHALMIC KNIFE W/REMOVALE DEPTH GUIDE is the device name listed in this FDA 510(k) record. The listed applicant is Myocure, Inc.. It received FDA 510(k) clearance on 1985-11-04 under 510(k) number K853598. The device is classified under product code HNN. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPHTHALMIC KNIFE W/REMOVALE DEPTH GUIDE?

OPHTHALMIC KNIFE W/REMOVALE DEPTH GUIDE is a medical device that received FDA 510(k) clearance on 1985-11-04. The listed applicant is Myocure, Inc.. The 510(k) number is K853598.

When did OPHTHALMIC KNIFE W/REMOVALE DEPTH GUIDE receive FDA 510(k) clearance?

OPHTHALMIC KNIFE W/REMOVALE DEPTH GUIDE received FDA 510(k) clearance on 1985-11-04, under 510(k) number K853598.

Who is the listed applicant for OPHTHALMIC KNIFE W/REMOVALE DEPTH GUIDE?

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

What is the FDA product code for OPHTHALMIC KNIFE W/REMOVALE DEPTH GUIDE?

The FDA product code for OPHTHALMIC KNIFE W/REMOVALE DEPTH GUIDE is HNN.

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Other records listing Myocure, 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.

K880345CYSTOTOMES/KNIFESK880346CANNULASK880347ANESTHESIA/RETROBULBAR NEEDLESK874057OPHTHALMIC TIP & BLADE SCALPELSK874056OPHTHALMIC DISPOSABLE BLADESK873385OPHTHALMIC PHACO-BLADE

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Related Devices (Code: HNN)

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.

K110166CLEARCUT S SAFETY KNIFEAlcon Research, Ltd.K922378OPHTHALMIC KNIFEMicroptics Development LaboratoryK882402RETRACTIVE INCISION MICROMETER (RIM) GUAGEOptical CenterK881669MVR/STILETTO BLADE 20GA. - P/N 1900Advanced Surgical Products, Inc.K874979PRISMA DISPOSABLE MVR/STILETTO BLADEAdvanced Surgical Products, Inc.K874057OPHTHALMIC TIP & BLADE SCALPELSMyocure, 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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