Universal Seal (5-12 mm)— 510(k) K261249
Substantially EquivalentIntuitive Surgical, Inc.
FDA 510(k) clearance K261249 for Universal Seal (5-12 mm), Substantially Equivalent on 2026-07-14. Applicant: Intuitive Surgical, Inc.. Device class: 2.
Summary
Intuitive Surgical's Universal Seal (5-12 mm) is filed under GCJ, laparoscopes for general and plastic surgery. The device name describes a seal, which the code name doesn't mention, and the record doesn't explain the fit.
Class II, 21 CFR 876.1500. The General and Plastic Surgery review panel handled it as a Traditional 510(k), though the record lists Gastroenterology and Urology as the classification panel.
Intuitive Surgical filed from Sunnyvale, California. Review took 89 calendar days (April 16 to July 14, 2026).
Clearance details
- Applicant
- Intuitive Surgical, Inc.
- Product code
- Product code GCJ
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sunnyvale, CA, US
Recent devices under product code GCJ
view allMore clearances from Intuitive Surgical, Inc.
view allAdverse events under product code GCJ
product code GCJ- Death
- 39
- Injury
- 1,638
- Malfunction
- 28,216
- Other
- 11
- Total
- 29,904
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.