FDA 510(k)

OPHTHALMIC SURGICAL SPECULUM

K-Number: K863664 · 1986-09-25

Decision Date1986-09-25

Product CodeHNC

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

OPHTHALMIC SURGICAL SPECULUM is the device name listed in this FDA 510(k) record. The listed applicant is Myocure, Inc.. It received FDA 510(k) clearance on 1986-09-25 under 510(k) number K863664. The device is classified under product code HNC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPHTHALMIC SURGICAL SPECULUM?

OPHTHALMIC SURGICAL SPECULUM is a medical device that received FDA 510(k) clearance on 1986-09-25. The listed applicant is Myocure, Inc.. The 510(k) number is K863664.

When did OPHTHALMIC SURGICAL SPECULUM receive FDA 510(k) clearance?

OPHTHALMIC SURGICAL SPECULUM received FDA 510(k) clearance on 1986-09-25, under 510(k) number K863664.

Who is the listed applicant for OPHTHALMIC SURGICAL SPECULUM?

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 SURGICAL SPECULUM?

The FDA product code for OPHTHALMIC SURGICAL SPECULUM is HNC.

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Other records listing Myocure, Inc. as applicant

K880346CANNULAS K880347ANESTHESIA/RETROBULBAR NEEDLES K880345CYSTOTOMES/KNIFES K874057OPHTHALMIC TIP & BLADE SCALPELS K874056OPHTHALMIC DISPOSABLE BLADES K873385OPHTHALMIC PHACO-BLADE

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Related Devices (Code: HNC)

K022836STEPHENS DISPOSABLE SPECULUMStephens Instruments K981235OCULOSTATLaser Center Dev. Corp.K964289EYE FIXATION SPECULUMEyefix, Inc.K863989THORNTON TITANIUM SPECULUM (MODIFIED BARRAQUER)Keeler Instruments, Inc.K843196VISITEC EYE SPECULUMVisitec Co.K830430EYELID SPECULUMDouglas C. Mckee & Co.

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.