ENDOSCOPIC MORTONS NEUROMA INSTRUMENTS— 510(k) K940230

Name: FDA 510(k) clearance K940230
Creator: U.S. Food and Drug Administration
Published: 1994-12-12

Substantially Equivalent

Instratek, Inc.

FDA 510(k) clearance K940230 for ENDOSCOPIC MORTONS NEUROMA INSTRUMENTS, Substantially Equivalent on 1994-12-12. Applicant: Instratek, Inc.. Device class: 2.

Clearance details

Applicant: Instratek, Inc.
Product code: Code HRX
Device class: Class 2
Regulation: 21 CFR 888.1100
Advisory panel: Orthopedic
Date received: 1994-01-14
Decision date: 1994-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HRX

product code HRX

Injury: 623
Malfunction: 11,257
Total: 11,880

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 →

Recalls naming K940230

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K940230.

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