OPTI-POINT— 510(k) K884781

Name: FDA 510(k) clearance K884781
Creator: U.S. Food and Drug Administration
Published: 1989-01-12

Substantially Equivalent

Plastic Injectors, Inc.

FDA 510(k) clearance K884781 for OPTI-POINT, Substantially Equivalent on 1989-01-12. Applicant: Plastic Injectors, Inc.. Device class: 2.

Clearance details

Applicant: Plastic Injectors, Inc.
Product code: Code HET
Device class: Class 2
Regulation: 21 CFR 884.1720
Advisory panel: Obstetrics/Gynecology
Date received: 1988-11-15
Decision date: 1989-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Spartanburg, SC, 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.