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FDA 510(k)

FLEXMEDICS NITINOL ARCH WIRE

K-Number: K863742 · 1986-11-24

ApplicantFlexmedics
Decision Date1986-11-24
Product CodeDZC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FLEXMEDICS NITINOL ARCH WIRE is the device name listed in this FDA 510(k) record. The listed applicant is Flexmedics. It received FDA 510(k) clearance on 1986-11-24 under 510(k) number K863742. The device is classified under product code DZC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLEXMEDICS NITINOL ARCH WIRE?

FLEXMEDICS NITINOL ARCH WIRE is a medical device that received FDA 510(k) clearance on 1986-11-24. The listed applicant is Flexmedics. The 510(k) number is K863742.

When did FLEXMEDICS NITINOL ARCH WIRE receive FDA 510(k) clearance?

FLEXMEDICS NITINOL ARCH WIRE received FDA 510(k) clearance on 1986-11-24, under 510(k) number K863742.

Who is the listed applicant for FLEXMEDICS NITINOL ARCH WIRE?

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

What is the FDA product code for FLEXMEDICS NITINOL ARCH WIRE?

The FDA product code for FLEXMEDICS NITINOL ARCH WIRE is DZC.

Related Clinical Trials

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Other records listing Flexmedics 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.

K990765FLEXFINDER GUIDE WIRE(REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS, FLEXFINDER GUIDE WIRE (REGULAR SHAFT/STIFF SHAFT) NOK964955FLEXFINDER GUIDEWIRE (REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS ENCAP+/GUIDEWIRE(REGULAR SHAFT/STIFF SHAFT) NO MARKINGK952430FINESSE GUIDEWIRE CORONARYK943390FLEXFINDER GUIDEWIREK942074FLEXFINDER GUIDEWIREK934265FLEXMEDICS SUPER-SEVEN STRANDED NICKEL-TITANIUM ARCHWIRE

View all 20 devices →

Related Devices (Code: DZC)

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.

K112640HYPERELASTIC WIREOrmco Corp.K943334HAWLEY RETAINER ORTHODONTIC APPLICANCE KITJay H. GellerK935638NITINOL, NITIHighland MetalsK935140DENTAURUM STEEL LIGATURE WIRESDentauraum, Inc.K935142DENTAURUM WIRESDentauraum, Inc.K934265FLEXMEDICS SUPER-SEVEN STRANDED NICKEL-TITANIUM ARCHWIREFlexmedics

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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