SAPPHIRE BLADE SURGICAL KNIFE— 510(k) K860852

Substantially Equivalent

Med-Tech Develoment Corp.

FDA 510(k) clearance K860852 for SAPPHIRE BLADE SURGICAL KNIFE, Substantially Equivalent on 1986-03-28. Applicant: Med-Tech Develoment Corp..

Clearance details

Applicant: Med-Tech Develoment Corp.
Product code: Code HNN
Advisory panel: Ophthalmic
Date received: 1986-03-07
Decision date: 1986-03-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clearwater, FL, US

Download summary PDF View on FDA.gov ↗

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.