ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler
K213633 is the FDA 510(k) clearance record for ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler, a class II device, cleared for Ethicon Endo-Surgery, LLC on under FDA product code GAG (Stapler, Surgical). FDA's definition for product code GAG reads: "A surgical stapler for internal use is a specialized prescription device used to deliver compatible staples to internal tissues during surgery for resection, transection, and creating anastomoses". FDA records list 185 510(k) clearances for Ethicon Endo-Surgery, LLC, from to . As of , FDA records show no recalls naming K213633.
Clearance record
- Decision date
- Received
- (142 days to decision)
- Product code
- GAG Stapler, Surgical
- Regulation
- 21 CFR 878.4740
- Device class
- Class II
- Review panel
- General Hospital
- Applicant
- Ethicon Endo-Surgery, LLC 475 Calle C, Guaynabo PR
- 510(k) summary
- Summary PDF
- Third party review
- No
Clearances, product code GAG
Trailing 12 monthsShow the numbers
| Month | Clearances |
|---|---|
| November 2025 | 0 |
| December 2025 | 0 |
| January 2026 | 0 |
| February 2026 | 0 |
| March 2026 | 0 |
| April 2026 | 0 |
| May 2026 | 0 |
| June 2026 | 0 |
| July 2026 | 1 |
| August 2026 | 0 |
| September 2026 | 0 |
| October 2026 | 0 |
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