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FDA 510(k)

SOFT TISSUE EXPANDER

K-Number: K923381 · 1993-05-05

ApplicantAcufex Microsurgical, Inc.
Decision Date1993-05-05
Product CodeHWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SOFT TISSUE EXPANDER 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 1993-05-05 under 510(k) number K923381. The device is classified under product code HWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOFT TISSUE EXPANDER?

SOFT TISSUE EXPANDER is a medical device that received FDA 510(k) clearance on 1993-05-05. The listed applicant is Acufex Microsurgical, Inc.. The 510(k) number is K923381.

When did SOFT TISSUE EXPANDER receive FDA 510(k) clearance?

SOFT TISSUE EXPANDER received FDA 510(k) clearance on 1993-05-05, under 510(k) number K923381.

Who is the listed applicant for SOFT TISSUE EXPANDER?

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 SOFT TISSUE EXPANDER?

The FDA product code for SOFT TISSUE EXPANDER is HWQ.

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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: HWQ)

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.

K970360MITEK SUTURE RETROGRADERMitek ProductsK920621ACUFEX PASSING PINS AND SURGICAL WIREAcufex Microsurgical, Inc.K885311MENISCUS MENDER II LOOPInstrument Makar, Inc.K843592VICO MICRO SURGICAL INSTRUMENTSVisitec Co.K841622SOFT-TISSUE INSTRUMENTPlastafil, Inc.K841623SLOTTED SOFT-TISSUE INSTRUMENTPlastafil, 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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