FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
Taurus Clip
K Number: K253734
·
Decision Mar 12, 2026
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
62
Applicant Total
1
Review Days
108
Basic Information
- Device Name
- Taurus Clip
- K Number
- K253734
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.4400
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Taurus Endoscopy
- Date Received
- November 24, 2025
- Decision Date
- March 12, 2026
- Product Code
- PKL
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| PKL | Hemostatic Metal Clip For The Gi Tract | FDA class 2 | Gastroenterology, Urology |
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