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FDA 510(k)

MENISCAL SUTURING SYSTEM

K-Number: K833943 · 1984-02-27

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

Device Summary

MENISCAL SUTURING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Dyonics, Inc.. It received FDA 510(k) clearance on 1984-02-27 under 510(k) number K833943. 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 MENISCAL SUTURING SYSTEM?

MENISCAL SUTURING SYSTEM is a medical device that received FDA 510(k) clearance on 1984-02-27. The listed applicant is Dyonics, Inc.. The 510(k) number is K833943.

When did MENISCAL SUTURING SYSTEM receive FDA 510(k) clearance?

MENISCAL SUTURING SYSTEM received FDA 510(k) clearance on 1984-02-27, under 510(k) number K833943.

Who is the listed applicant for MENISCAL SUTURING SYSTEM?

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

What is the FDA product code for MENISCAL SUTURING SYSTEM?

The FDA product code for MENISCAL SUTURING SYSTEM is LXH.

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Other records listing Dyonics, 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.

K900070MODIFIED USES OF THE ARTHROSCOPIC SURGICAL SYSTEMK896416DYONICS SHOULDER PORTAL SYSTEMK893136SURGI-PAK FOR ARTHROSCOPIC ACROMIOPLASTYK890665MODIFIED CANNULA, TROCAR AND OBTURATOR ACCESSORIESK894728DYONICS DISPOSABLE ARTHROSCOPIC SURGICAL KNIFEK892062PS3500 ARTHROSCOPIC SURGICAL SYSTEM

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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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