Endopath Xcel Bladeless Trocar with Optiview Technology Endopath Xcel Blunt Tip Trocar with Optiview Technology Endopath
K122511 is the FDA 510(k) clearance record for ENDOPATH XCEL BLADELESS TROCAR WITH OPTIVIEW TECHNOLOGY ENDOPATH XCEL BLUNT TIP TROCAR WITH OPTIVIEW TECHNOLOGY ENDOPATH, a class II device, cleared for Ethicon Endo-Surgery, LLC on under FDA product code GCJ (Laparoscope, General & Plastic Surgery). FDA's definition for product code GCJ reads: "Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available...". FDA records list 185 510(k) clearances for Ethicon Endo-Surgery, LLC, from to . As of , FDA records show no recalls naming K122511.
Clearance record
- Decision date
- Received
- (45 days to decision)
- Product code
- GCJ Laparoscope, General & Plastic Surgery
- Regulation
- 21 CFR 876.1500
- Device class
- Class II
- Review panel
- Gastroenterology, Urology
- Applicant
- Ethicon Endo-Surgery, LLC 4545 Creek Rd., Cincinnati OH
- 510(k) summary
- Summary PDF
- Third party review
- No
Clearances, product code GCJ
Trailing 12 monthsShow the numbers
| Month | Clearances |
|---|---|
| December 2025 | 0 |
| January 2026 | 3 |
| February 2026 | 4 |
| March 2026 | 0 |
| April 2026 | 3 |
| May 2026 | 4 |
| June 2026 | 4 |
| July 2026 | 3 |
| August 2026 | 2 |
| September 2026 | 2 |
| October 2026 | 1 |
| November 2026 | 0 |
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