KARL STORZ UDEL Sterilization Trays— 510(k) K201945
Substantially EquivalentKarl Storz Endoscopy America, Inc.
FDA 510(k) clearance K201945 for KARL STORZ UDEL Sterilization Trays, Substantially Equivalent on 2021-02-25. 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
Recent devices under product code KCT
view allMore clearances from Karl Storz Endoscopy America, Inc.
view allRecalls naming K201945
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K201945.
Data sourced from openFDA. This site is unofficial and independent of the FDA.