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FDA 510(k)

RETROGRADE KNIFE

K-Number: K954507 · 1995-11-14

ApplicantPhx Technologies Corp.
Decision Date1995-11-14
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

RETROGRADE KNIFE 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 1995-11-14 under 510(k) number K954507. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RETROGRADE KNIFE?

RETROGRADE KNIFE is a medical device that received FDA 510(k) clearance on 1995-11-14. The listed applicant is Phx Technologies Corp.. The 510(k) number is K954507.

When did RETROGRADE KNIFE receive FDA 510(k) clearance?

RETROGRADE KNIFE received FDA 510(k) clearance on 1995-11-14, under 510(k) number K954507.

Who is the listed applicant for RETROGRADE KNIFE?

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 RETROGRADE KNIFE?

The FDA product code for RETROGRADE KNIFE is HRX.

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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.

K974327WINGED NEEDLE HOLDERK971123STONE EXTRACTORK954510RRIANGLE KNIFEK954508RETRACTORK954509PROBE KNIFEK954464CARPAL TUNNEL SLOTTED CANNULA

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Related Devices (Code: HRX)

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.

K260203Fule Vertebroplasty Balloon CatheterBeijing Fule Science & Technology Development Co., Ltd.K254103HOPKINS Telescopes for ArthroscopyKarl Storz SE & CO. KGK252790Digital ClarusScope System and Digital NeuroPEN SystemClarus Medical, LLCK253523Freedom DS™ Decompression SystemSpinal SimplicityK252546VantageTM Lumbar Decompression KitAllevion Medical, LLCK253217MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)Medimaging Integrated Solution, Inc (Miis)

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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