ACUFEX INTRA ARTICULAR MEASURING DEVICE— 510(k) K925335

Name: FDA 510(k) clearance K925335
Creator: U.S. Food and Drug Administration
Published: 1992-12-29

Substantially Equivalent

Acufex Microsurgical, Inc.

FDA 510(k) clearance K925335 for ACUFEX INTRA ARTICULAR MEASURING DEVICE, Substantially Equivalent on 1992-12-29. Applicant: Acufex Microsurgical, Inc.. Device class: 1.

Clearance details

Applicant: Acufex Microsurgical, Inc.
Product code: Code HTJ
Device class: Class 1
Regulation: 21 CFR 888.4300
Advisory panel: Orthopedic
Date received: 1992-10-22
Decision date: 1992-12-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mansfield, MA, US

Download summary PDF View on FDA.gov ↗

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K864426 — RAYLOR(TM) DEPTH GAUGE1986-11-26

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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 HTJ

product code HTJ

Malfunction: 2,320
Total: 2,320

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.