ACUFEX PASSING PINS AND SURGICAL WIRE— 510(k) K920621

Name: FDA 510(k) clearance K920621
Creator: U.S. Food and Drug Administration
Published: 1993-05-05

Substantially Equivalent

Acufex Microsurgical, Inc.

FDA 510(k) clearance K920621 for ACUFEX PASSING PINS AND SURGICAL WIRE, Substantially Equivalent on 1993-05-05. Applicant: Acufex Microsurgical, Inc.. Device class: 1.

Clearance details

Applicant: Acufex Microsurgical, Inc.
Product code: Code HWQ
Device class: Class 1
Regulation: 21 CFR 888.4540
Advisory panel: Orthopedic
Date received: 1992-02-11
Decision date: 1993-05-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Great Neck, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HWQ

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K970360 — MITEK SUTURE RETROGRADER1997-03-10
K923381 — SOFT TISSUE EXPANDER1993-05-05
K885311 — MENISCUS MENDER II LOOP1989-02-09
K843592 — VICO MICRO SURGICAL INSTRUMENTS1984-10-05
K841622 — SOFT-TISSUE INSTRUMENT1984-07-11

More clearances from Acufex Microsurgical, Inc.

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K961555 — ACUFEX TAG BIOABSORBABLE ANCHORS1996-07-10
K961853 — PROLINE FAST PASS ARTHOSCOPIC NEEDLE PASSER1996-06-21
K954246 — ACUFEX ENDOFIX ABSORBABLE INTERFERENCE SCREW1996-02-15
K952535 — ACUFEX ENDOBUTTON TAPE1996-02-08
K953276 — ACUFEX TAG DELIVERY SYSTEM1995-10-05

Adverse events under product code HWQ

product code HWQ

Injury: 137
Malfunction: 443
Total: 580

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.