BELLOTA SONOHYSTEROGRAPHY CATHETER WITH CERVICAL CONE, BELLOTA SONOHYSTEROGRAPHY CATHETER WITHOUT CERVICAL CONE— 510(k) K102898

Name: FDA 510(k) clearance K102898
Creator: U.S. Food and Drug Administration
Published: 2011-12-15

Substantially Equivalent

Panpac Medical Corporation

FDA 510(k) clearance K102898 for BELLOTA SONOHYSTEROGRAPHY CATHETER WITH CERVICAL CONE, BELLOTA SONOHYSTEROGRAPHY CATHETER WITHOUT CERVICAL CONE, Substantially Equivalent on 2011-12-15. Applicant: Panpac Medical Corporation. Device class: 2.

Clearance details

Applicant: Panpac Medical Corporation
Product code: Code LKF
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 2010-09-30
Decision date: 2011-12-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shi-Chih City, Taipei Hsien, TW

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LKF

product code LKF

Malfunction: 643
Other: 2
Total: 645

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.