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FDA 510(k)

FLEXMEDICS SUPER-SEVEN STRANDED NICKEL-TITANIUM ARCHWIRE

K-Number: K934265 · 1994-01-21

ApplicantFlexmedics
Decision Date1994-01-21
Product CodeDZC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FLEXMEDICS SUPER-SEVEN STRANDED NICKEL-TITANIUM ARCHWIRE is the device name listed in this FDA 510(k) record. The listed applicant is Flexmedics. It received FDA 510(k) clearance on 1994-01-21 under 510(k) number K934265. 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 SUPER-SEVEN STRANDED NICKEL-TITANIUM ARCHWIRE?

FLEXMEDICS SUPER-SEVEN STRANDED NICKEL-TITANIUM ARCHWIRE is a medical device that received FDA 510(k) clearance on 1994-01-21. The listed applicant is Flexmedics. The 510(k) number is K934265.

When did FLEXMEDICS SUPER-SEVEN STRANDED NICKEL-TITANIUM ARCHWIRE receive FDA 510(k) clearance?

FLEXMEDICS SUPER-SEVEN STRANDED NICKEL-TITANIUM ARCHWIRE received FDA 510(k) clearance on 1994-01-21, under 510(k) number K934265.

Who is the listed applicant for FLEXMEDICS SUPER-SEVEN STRANDED NICKEL-TITANIUM ARCHWIRE?

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 SUPER-SEVEN STRANDED NICKEL-TITANIUM ARCHWIRE?

The FDA product code for FLEXMEDICS SUPER-SEVEN STRANDED NICKEL-TITANIUM ARCHWIRE is DZC.

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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 GUIDEWIREK912843FLEXMEDICS RETRACT ORTH PROBE, PETTINE BONE PROBE

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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.K933374NITI COIL SPRINGSHighland Metals

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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