Universal Seal (5-12 mm)— 510(k) K253978
Substantially EquivalentIntuitive Surgical, Inc.
FDA 510(k) clearance K253978 for Universal Seal (5-12 mm), Substantially Equivalent on 2026-02-24. Applicant: Intuitive Surgical, Inc.. Device class: 2.
Summary
Intuitive Surgical's Universal Seal carries 5-12 mm in parentheses in its name. It's filed under product code GCJ (Laparoscope, General & Plastic Surgery), and the record doesn't describe the seal further.
Class II, 21 CFR 876.1500. The General, Plastic Surgery review panel handled it as a Traditional 510(k), though the record lists Gastroenterology, Urology as the classification panel.
Intuitive Surgical filed from Sunnyvale, California. The substantially equivalent decision came 74 calendar days after receipt (December 12, 2025 to February 24, 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.