DeviceClearance

Endomat Select (UP220)— 510(k) K261706

Substantially Equivalent

KARL STORZ SE & CO. KG

FDA 510(k) clearance K261706 for Endomat Select (UP220), Substantially Equivalent on 2026-07-16. Applicant: KARL STORZ SE & CO. KG. Device class: 2.

Summary

KARL STORZ's Endomat Select (UP220) is filed under HIG, hysteroscopic insufflators. The record gives the model as UP220 but no specs.

Class II, 21 CFR 884.1700. Obstetrics and Gynecology is both the classification panel and the review panel, and it came in as a Traditional 510(k).

KARL STORZ filed from Tuttlingen, Germany. Review took 55 calendar days (May 22 to July 16, 2026).

Clearance details

Applicant
KARL STORZ SE & CO. KG
Product code
Product code HIG
Device class
Class 2
Regulation
21 CFR 884.1700
Advisory panel
Obstetrics/Gynecology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Tuttlingen, DE
Download summary PDFView on FDA.gov ↗

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Adverse events under product code HIG

product code HIG
Death
8
Other
2
Total
10

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.