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FDA 510(k)

WINGED NEEDLE HOLDER

K-Number: K974327 · 1998-01-09

ApplicantPhx Technologies Corp.
Decision Date1998-01-09
Product CodeFHQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

WINGED NEEDLE HOLDER is the device name listed in this FDA 510(k) record. The listed applicant is Phx Technologies Corp.. It received FDA 510(k) clearance on 1998-01-09 under 510(k) number K974327. The device is classified under product code FHQ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WINGED NEEDLE HOLDER?

WINGED NEEDLE HOLDER is a medical device that received FDA 510(k) clearance on 1998-01-09. The listed applicant is Phx Technologies Corp.. The 510(k) number is K974327.

When did WINGED NEEDLE HOLDER receive FDA 510(k) clearance?

WINGED NEEDLE HOLDER received FDA 510(k) clearance on 1998-01-09, under 510(k) number K974327.

Who is the listed applicant for WINGED NEEDLE HOLDER?

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

What is the FDA product code for WINGED NEEDLE HOLDER?

The FDA product code for WINGED NEEDLE HOLDER is FHQ.

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Other records listing Phx Technologies Corp. 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.

K971123STONE EXTRACTORK954510RRIANGLE KNIFEK954509PROBE KNIFEK954507RETROGRADE KNIFEK954508RETRACTORK954464CARPAL TUNNEL SLOTTED CANNULA

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Related Devices (Code: FHQ)

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.

K924196LAPAROSCOPIC NEEDLE HOLDERNusurg, Inc.K930330ENDOSCOPIC NEEDLEHOLDER, MODIFICATIONHolmed Corp.K920706MAGNETIC POINT GUARD FOR SURGICAL NEEDLESRetraxK85177925-100,25-220 VARIOUS NEEDLE HOLDERSArtiberiaK85178025-230 TO 25-390 VARIOUS NEEDLE HOLDERSArtiberiaK771859NEEDLE HOLDER, MICROVASCULAREdward Weck, 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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