FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KARL STORZ Trocars with Valve Seals
K Number: K254228
·
Decision May 11, 2026
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
1422
Applicant Total
25
Review Days
136
Basic Information
- Device Name
- KARL STORZ Trocars with Valve Seals
- K Number
- K254228
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Karl Storz SE & CO. KG
- Date Received
- December 26, 2025
- Decision Date
- May 11, 2026
- Product Code
- GCJ
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Karl Storz SE & CO. KG
| K Number | Device Name | ||
|---|---|---|---|
| K252800 | KARL STORZ Endoscopic Accessories for Urology | Jun 3, 2026 | Substantially Equivalent |
| K260003 | KARL STORZ Mediastinoscopes and Instruments | Mar 2, 2026 | Substantially Equivalent |
| K254242 | KARL STORZ ICG Imaging System with RUBINA® Lens | Feb 26, 2026 | Substantially Equivalent |
| K253972 | IMAGE1 (TC400US); X-to-4U Adapter (TC040) | Feb 12, 2026 | Substantially Equivalent |
| K251731 | KARL STORZ Flexible Intubation Video Endoscope Sterile (FIVE-S) (0916612) | Dec 5, 2025 | Substantially Equivalent |
| K250927 | KARL STORZ Cholangiography Set | Nov 22, 2025 | Substantially Equivalent |
| K253411 | Miniature Telescope for Urology (27033AA) | Nov 18, 2025 | Substantially Equivalent |
| K250388 | ENDOFLATOR + | Sep 22, 2025 | Substantially Equivalent |
| K243653 | KARL STORZ HOPKINS Telescopes for Urology | Aug 13, 2025 | Substantially Equivalent |
| K243550 | KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC) | Jun 6, 2025 | Substantially Equivalent |