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FDA 510(k)

ACUFEX SUTURE RETRIEVER, STERILE DISPOSABLE

K-Number: K881224 · 1988-06-01

ApplicantAcufex Microsurgical, Inc.
Decision Date1988-06-01
Product CodeGAE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ACUFEX SUTURE RETRIEVER, STERILE DISPOSABLE 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 1988-06-01 under 510(k) number K881224. The device is classified under product code GAE. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACUFEX SUTURE RETRIEVER, STERILE DISPOSABLE?

ACUFEX SUTURE RETRIEVER, STERILE DISPOSABLE is a medical device that received FDA 510(k) clearance on 1988-06-01. The listed applicant is Acufex Microsurgical, Inc.. The 510(k) number is K881224.

When did ACUFEX SUTURE RETRIEVER, STERILE DISPOSABLE receive FDA 510(k) clearance?

ACUFEX SUTURE RETRIEVER, STERILE DISPOSABLE received FDA 510(k) clearance on 1988-06-01, under 510(k) number K881224.

Who is the listed applicant for ACUFEX SUTURE RETRIEVER, STERILE DISPOSABLE?

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 SUTURE RETRIEVER, STERILE DISPOSABLE?

The FDA product code for ACUFEX SUTURE RETRIEVER, STERILE DISPOSABLE is GAE.

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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: GAE)

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.

K950776BIPOLAR SNARECook Urological, Inc.K926036ACUFEX SUTURE RETRIEVERAcufex Microsurgical, Inc.K903174ADVANCE SUTURE ABSORBABLE GUT SUTUREAdvance Suture, Inc.

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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