MIYA SPECULUM— 510(k) K891041

Substantially Equivalent

Zinnanti Surgical Instruments, Inc.

FDA 510(k) clearance K891041 for MIYA SPECULUM, Substantially Equivalent on 1989-03-22. Applicant: Zinnanti Surgical Instruments, Inc..

Clearance details

Applicant: Zinnanti Surgical Instruments, Inc.
Product code: Code HDF
Advisory panel: Obstetrics/Gynecology
Date received: 1989-02-28
Decision date: 1989-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chatsworth, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HDF

product code HDF

Other: 2
Total: 2

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.