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FDA 510(k)

CRANE MENISCAL SUTURE SET

K-Number: K834369 · 1984-02-27

ApplicantAcufex Microsurgical, Inc.
Decision Date1984-02-27
Product CodeLXH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CRANE MENISCAL SUTURE SET 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 1984-02-27 under 510(k) number K834369. The device is classified under product code LXH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRANE MENISCAL SUTURE SET?

CRANE MENISCAL SUTURE SET is a medical device that received FDA 510(k) clearance on 1984-02-27. The listed applicant is Acufex Microsurgical, Inc.. The 510(k) number is K834369.

When did CRANE MENISCAL SUTURE SET receive FDA 510(k) clearance?

CRANE MENISCAL SUTURE SET received FDA 510(k) clearance on 1984-02-27, under 510(k) number K834369.

Who is the listed applicant for CRANE MENISCAL SUTURE SET?

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 CRANE MENISCAL SUTURE SET?

The FDA product code for CRANE MENISCAL SUTURE SET is LXH.

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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 ANCHORSK961853PROLINE FAST PASS ARTHOSCOPIC NEEDLE PASSERK954246ACUFEX ENDOFIX ABSORBABLE INTERFERENCE SCREWK952535ACUFEX ENDOBUTTON TAPEK953276ACUFEX TAG DELIVERY SYSTEMK953459ACUFEX TAG ANCHOR

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Related Devices (Code: LXH)

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.

K192873SX-One MicroKnifeSonex Health, Inc.K101609SELF RETAINING SOFT TISSUE RETRACTORKoros USA, Inc.K001507MICROPERFORATION INSTRUMENTSmith & Nephew, Inc.K952495ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEMOrthopedic Systems, Inc.K943873ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SYOrthomet, Inc.K944188SPINAL MARKERLeibinger L.P.

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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