SPECULITE— 510(k) K953364

Name: FDA 510(k) clearance K953364
Creator: U.S. Food and Drug Administration
Published: 1995-12-08

Substantially Equivalent

Trylon Corp.

FDA 510(k) clearance K953364 for SPECULITE, Substantially Equivalent on 1995-12-08. Applicant: Trylon Corp.. Device class: 2.

Clearance details

Applicant: Trylon Corp.
Product code: Code HET
Device class: Class 2
Regulation: 21 CFR 884.1720
Advisory panel: Obstetrics/Gynecology
Date received: 1995-07-17
Decision date: 1995-12-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Monarch Beach, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HET

product code HET

Malfunction: 10,504
Total: 10,504

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.