510(k) K254228
- Device
- KARL STORZ Trocars with Valve Seals
- Applicant
- Karl Storz SE & CO. KG
- 510(k) number
- K254228
- Product code
- GCJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-05-11
- Date received
- 2025-12-26
- Regulation
- 876.1500
- Classification name
- Laparoscope, General & Plastic Surgery
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Mario Trujillo
- Address
- Dr.-Karl-Storz-Straße 34 Baden-Wurttemberg Tuttlingen DE US 78562 78562
FDA Registration Numbers
- 3002808148
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Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
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