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FDA 510(k)

PROLINE FAST PASS ARTHOSCOPIC NEEDLE PASSER

K-Number: K961853 · 1996-06-21

ApplicantAcufex Microsurgical, Inc.
Decision Date1996-06-21
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PROLINE FAST PASS ARTHOSCOPIC NEEDLE PASSER is the device name listed in this FDA 510(k) record. The listed applicant is Acufex Microsurgical, Inc.. It received FDA 510(k) clearance on 1996-06-21 under 510(k) number K961853. 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 PROLINE FAST PASS ARTHOSCOPIC NEEDLE PASSER?

PROLINE FAST PASS ARTHOSCOPIC NEEDLE PASSER is a medical device that received FDA 510(k) clearance on 1996-06-21. The listed applicant is Acufex Microsurgical, Inc.. The 510(k) number is K961853.

When did PROLINE FAST PASS ARTHOSCOPIC NEEDLE PASSER receive FDA 510(k) clearance?

PROLINE FAST PASS ARTHOSCOPIC NEEDLE PASSER received FDA 510(k) clearance on 1996-06-21, under 510(k) number K961853.

Who is the listed applicant for PROLINE FAST PASS ARTHOSCOPIC NEEDLE PASSER?

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

What is the FDA product code for PROLINE FAST PASS ARTHOSCOPIC NEEDLE PASSER?

The FDA product code for PROLINE FAST PASS ARTHOSCOPIC NEEDLE PASSER is HRX.

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Other records listing Acufex Microsurgical, 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.

K961555ACUFEX TAG BIOABSORBABLE ANCHORSK954246ACUFEX ENDOFIX ABSORBABLE INTERFERENCE SCREWK952535ACUFEX ENDOBUTTON TAPEK953276ACUFEX TAG DELIVERY SYSTEMK953459ACUFEX TAG ANCHORK941740ACUFEX ROTATOR CUFF FIXATION BUTTON

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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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