da Vinci SP SureForm 45 Staplers and Reloads (SP1098)— 510(k) K243596
Substantially EquivalentIntuitive Surgical, Inc.
FDA 510(k) clearance K243596 for da Vinci SP SureForm 45 Staplers and Reloads (SP1098), Substantially Equivalent on 2025-03-10. Applicant: Intuitive Surgical, Inc.. Device class: 2.
Clearance details
- Applicant
- Intuitive Surgical, Inc.
- Product code
- Code GAG
- Device class
- Class 2
- Regulation
- 21 CFR 878.4740
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sunnyvale, CA, US
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- K241629 — ECHELON 3000 45mm Compact Stapler (ECH45C) +5 more
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More clearances from Intuitive Surgical, Inc.
view allAdverse events under product code GAG
product code GAG- Death
- 23
- Injury
- 394
- Malfunction
- 2,304
- Other
- 6
- Total
- 2,727
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.