DeviceClearance

Karl Storz Radel Sterilization Trays— 510(k) K203572

Substantially Equivalent

Karl Storz Endoscopy America, Inc.

FDA 510(k) clearance K203572 for Karl Storz Radel Sterilization Trays, Substantially Equivalent on 2021-05-07. Applicant: Karl Storz Endoscopy America, Inc.. Device class: 2.

Clearance details

Applicant
Karl Storz Endoscopy America, Inc.
Product code
Code KCT
Device class
Class 2
Regulation
21 CFR 880.6850
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
El Segundo, CA, US
Download summary PDFView on FDA.gov ↗

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Recalls naming K203572

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K203572.

Data sourced from openFDA. This site is unofficial and independent of the FDA.