VAGINAL SPECULUM— 510(k) K890375

Substantially Equivalent

Kinetic Medical Products

FDA 510(k) clearance K890375 for VAGINAL SPECULUM, Substantially Equivalent on 1989-02-13. Applicant: Kinetic Medical Products.

Clearance details

Applicant
Kinetic Medical Products
Product code
Code HDF
Advisory panel
Obstetrics/Gynecology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Erie, PA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code HDF

product code HDF
Other
2
Total
2

Source: openFDA MAUDE database, through . 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.