FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Universal Seal (5-12 mm)
K Number: K253978
·
Decision Feb 24, 2026
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
1422
Applicant Total
176
Review Days
74
Basic Information
- Device Name
- Universal Seal (5-12 mm)
- K Number
- K253978
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Intuitive Surgical, Inc.
- Date Received
- December 12, 2025
- Decision Date
- February 24, 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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|---|---|---|---|
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| K251763 | IRISeg | Dec 16, 2025 | Substantially Equivalent |
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| K252069 | da Vinci SP Surgical System (SP1098) | Dec 2, 2025 | Substantially Equivalent |
| K251426 | da Vinci SP Surgical System (SP1098) | Oct 3, 2025 | Substantially Equivalent |
| K252045 | Ion Endoluminal System (IF1000) | Sep 23, 2025 | Substantially Equivalent |
| K251817 | da Vinci SP Surgical System (SP1098) | Sep 10, 2025 | Substantially Equivalent |
| K251227 | da Vinci Surgical System (IS5000) | Sep 8, 2025 | Substantially Equivalent |