Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS)
K260580 is the FDA 510(k) clearance record for Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS), a class II device, cleared for Olympus Medical Systems Corp. on under FDA product code PKL (Hemostatic Metal Clip For The Gi Tract). FDA's definition for product code PKL reads: "Clip placement within the gastrointestinal (GI) tract for the purpose of endoscopic marking, hemostasis for mucosal/sub-mucosal defects, bleeding ulcers, arteries, polyps, diverticula in the colon, prophylactic clipping, anchoring feeding...". FDA records list 186 510(k) clearances for Olympus Medical Systems Corp., from to . As of , FDA records show no recalls naming K260580.
Clearance record
- Decision date
- Received
- (90 days to decision)
- Product code
- PKL Hemostatic Metal Clip For The Gi Tract
- Regulation
- 21 CFR 876.4400
- Device class
- Class II
- Review panel
- Gastroenterology, Urology
- Applicant
- Olympus Medical Systems Corp. 2951 Ishikawa-Cho, Hachioji-Shi, JP
- 510(k) summary
- Summary PDF
- Third party review
- No
Clearances, product code PKL
Trailing 12 monthsShow the numbers
| Month | Clearances |
|---|---|
| November 2025 | 1 |
| December 2025 | 1 |
| January 2026 | 0 |
| February 2026 | 0 |
| March 2026 | 1 |
| April 2026 | 1 |
| May 2026 | 1 |
| June 2026 | 0 |
| July 2026 | 0 |
| August 2026 | 1 |
| September 2026 | 1 |
| October 2026 | 0 |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
