FDA 510(k)

ACUFEX PASSING PINS AND SURGICAL WIRE

K-Number: K920621 · 1993-05-05

Decision Date1993-05-05

Product CodeHWQ

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

ACUFEX PASSING PINS AND SURGICAL WIRE 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 K920621. 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 ACUFEX PASSING PINS AND SURGICAL WIRE?

ACUFEX PASSING PINS AND SURGICAL WIRE 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 K920621.

When did ACUFEX PASSING PINS AND SURGICAL WIRE receive FDA 510(k) clearance?

ACUFEX PASSING PINS AND SURGICAL WIRE received FDA 510(k) clearance on 1993-05-05, under 510(k) number K920621.

Who is the listed applicant for ACUFEX PASSING PINS AND SURGICAL WIRE?

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 PASSING PINS AND SURGICAL WIRE?

The FDA product code for ACUFEX PASSING PINS AND SURGICAL WIRE is HWQ.

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Other records listing Acufex Microsurgical, Inc. as applicant

K961555ACUFEX TAG BIOABSORBABLE ANCHORS K961853PROLINE FAST PASS ARTHOSCOPIC NEEDLE PASSER K954246ACUFEX ENDOFIX ABSORBABLE INTERFERENCE SCREW K952535ACUFEX ENDOBUTTON TAPE K953276ACUFEX TAG DELIVERY SYSTEM K953459ACUFEX TAG ANCHOR

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Related Devices (Code: HWQ)

K970360MITEK SUTURE RETROGRADERMitek Products K923381SOFT TISSUE EXPANDERAcufex 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.