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FDA 510(k)

ACUFEX TAG BIOABSORBABLE ANCHORS

K-Number: K961555 · 1996-07-10

ApplicantAcufex Microsurgical, Inc.
Decision Date1996-07-10
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ACUFEX TAG BIOABSORBABLE ANCHORS 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 1996-07-10 under 510(k) number K961555. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACUFEX TAG BIOABSORBABLE ANCHORS?

ACUFEX TAG BIOABSORBABLE ANCHORS is a medical device that received FDA 510(k) clearance on 1996-07-10. The listed applicant is Acufex Microsurgical, Inc.. The 510(k) number is K961555.

When did ACUFEX TAG BIOABSORBABLE ANCHORS receive FDA 510(k) clearance?

ACUFEX TAG BIOABSORBABLE ANCHORS received FDA 510(k) clearance on 1996-07-10, under 510(k) number K961555.

Who is the listed applicant for ACUFEX TAG BIOABSORBABLE ANCHORS?

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 ACUFEX TAG BIOABSORBABLE ANCHORS?

The FDA product code for ACUFEX TAG BIOABSORBABLE ANCHORS is JDR.

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Other records listing Acufex Microsurgical, Inc. as applicant

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Related Devices (Code: JDR)

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K262451Arthrex DynaNite StaplesArthrex, Inc.K261121Megalodon Dynamic Compression SystemParagon 28, Inc.K250712Linkt Compression Staple SystemTrax SurgicalK243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LPK243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.K243658TMC Compression Implant SystemTreace Medical Concepts

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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