MICRA DIAMOND KNIFE MICRA ADJUSTABLE KNIFE— 510(k) K844553

Substantially Equivalent

Codman & Shurtleff, Inc.

FDA 510(k) clearance K844553 for MICRA DIAMOND KNIFE MICRA ADJUSTABLE KNIFE, Substantially Equivalent on 1984-12-11. Applicant: Codman & Shurtleff, Inc..

Clearance details

Applicant: Codman & Shurtleff, Inc.
Product code: Code HNN
Advisory panel: Ophthalmic
Date received: 1984-11-21
Decision date: 1984-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Randolph, MA, US

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Adverse events under product code HNN

product code HNN

Injury: 183
Malfunction: 4,106
Total: 4,289

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.