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FDA 510(k)

SURGISCRIBE MARKING PEN

K-Number: K840470 · 1984-03-12

ApplicantSurgicot, Inc.
Decision Date1984-03-12
Product CodeFZZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGISCRIBE MARKING PEN is the device name listed in this FDA 510(k) record. The listed applicant is Surgicot, Inc.. It received FDA 510(k) clearance on 1984-03-12 under 510(k) number K840470. 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 SURGISCRIBE MARKING PEN?

SURGISCRIBE MARKING PEN is a medical device that received FDA 510(k) clearance on 1984-03-12. The listed applicant is Surgicot, Inc.. The 510(k) number is K840470.

When did SURGISCRIBE MARKING PEN receive FDA 510(k) clearance?

SURGISCRIBE MARKING PEN received FDA 510(k) clearance on 1984-03-12, under 510(k) number K840470.

Who is the listed applicant for SURGISCRIBE MARKING PEN?

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

What is the FDA product code for SURGISCRIBE MARKING PEN?

The FDA product code for SURGISCRIBE MARKING PEN is FZZ.

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Other records listing Surgicot, 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.

K962605PRO-GUARD DOUBLE-DUTY STERILIZATION WRAP (SINGLE USE)K931270SURGICLEAN ENZYMATIC INSTRUMENT CLEANERK863122ASSERT BIOLOGICAL/CHEMICAL INDICATOR 12 MONTH EXP.K855101ASSERT TM BIOLOGICAL/CHEMICAL INDICATORK854631ASSERT EO BIOLOGICAL TEST PACKK854902SURGICOT STEAM TEST PACK

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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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