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FDA 510(k)

SURGICAL SKIN MARKER

K-Number: K864371 · 1986-11-17

ApplicantMyocure, Inc.
Decision Date1986-11-17
Product CodeFZZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGICAL SKIN MARKER is the device name listed in this FDA 510(k) record. The listed applicant is Myocure, Inc.. It received FDA 510(k) clearance on 1986-11-17 under 510(k) number K864371. The device is classified under product code FZZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGICAL SKIN MARKER?

SURGICAL SKIN MARKER is a medical device that received FDA 510(k) clearance on 1986-11-17. The listed applicant is Myocure, Inc.. The 510(k) number is K864371.

When did SURGICAL SKIN MARKER receive FDA 510(k) clearance?

SURGICAL SKIN MARKER received FDA 510(k) clearance on 1986-11-17, under 510(k) number K864371.

Who is the listed applicant for SURGICAL SKIN MARKER?

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 SURGICAL SKIN MARKER?

The FDA product code for SURGICAL SKIN MARKER is FZZ.

Related Clinical Trials

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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/KNIFESK880347ANESTHESIA/RETROBULBAR NEEDLESK880346CANNULASK874057OPHTHALMIC TIP & BLADE SCALPELSK874056OPHTHALMIC DISPOSABLE BLADESK873385OPHTHALMIC PHACO-BLADE

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Related Devices (Code: FZZ)

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.

K042555SURGICHIP TAG SURGICAL MARKERSurgichip, Inc.K915066DISPOSABLE SKIN MARKERAmerican Medical Mfg., Inc.K914759BLOOM TRANSPARENT STENCILFreckles Publications, Inc.K912730ROCKET SURGICAL SKIN MARKING PENWest Texas Lighthouse For the BlindK905143SKIN MARKERAesculap, Inc.K904559QUALTEX SKIN MARKERQualtex, 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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