FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Universal Cannula Seal (5-12 mm)
K Number: K181395
·
Decision Jul 27, 2018
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
1422
Applicant Total
176
Review Days
59
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Universal Cannula Seal (5-12 mm)
- K Number
- K181395
- 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
- May 29, 2018
- Decision Date
- July 27, 2018
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GCJ), ordered by most recent decision date.
FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm, 30 Degree FloShield Air, FSS-03-1045T - 10mm, 45 Degree FloShield Air, FSS-01-0500T - 5mm, 0 Degree FloShield Air, FSS-02-0530T - 5mm, 30 Degree FloShield Air, FSS-01-0545T - 5mm, 45 Degree FloShield Air)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Tech-Image Video Endoscope System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TroKit Laparoscope Lens Wiper
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Inno-Port Disposable Bladed Trocar
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
4K NIR/ICG Imaging System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MediBot Needle Driver Uno
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Intuitive Surgical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K253986 | da Vinci Force Feedback Instruments | Mar 11, 2026 | Substantially Equivalent |
| K253978 | Universal Seal (5-12 mm) | Feb 24, 2026 | Substantially Equivalent |
| K251739 | da Vinci Surgical System (IS5000) | Jan 16, 2026 | Substantially Equivalent |
| K253556 | da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator | Jan 16, 2026 | Substantially Equivalent |
| K251763 | IRISeg | Dec 16, 2025 | Substantially Equivalent |
| K252675 | da Vinci SP Surgical System (SP1098) | Dec 15, 2025 | Substantially Equivalent |
| 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 |