FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
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)
K Number: K260580
·
Decision May 21, 2026
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
62
Applicant Total
102
Review Days
90
Basic Information
- Device Name
- 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)
- K Number
- K260580
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.4400
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Olympus Medical Systems Corp.
- Date Received
- February 20, 2026
- Decision Date
- May 21, 2026
- Product Code
- PKL
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PKL | Hemostatic Metal Clip For The Gi Tract | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Olympus Medical Systems Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K252341 | EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190) | Apr 23, 2026 | Substantially Equivalent |
| K251807 | Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR | Mar 6, 2026 | Substantially Equivalent |
| K253646 | Single Use Distal Cover MAJ-2315 (MAJ-2315) | Feb 22, 2026 | Substantially Equivalent |
| K251336 | VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light Source Olympus CLL-S700 (CLL-S700); 4K Camera Head Olympus CH-S700-XZ-EA (CH-S700-XZ-EA) | Nov 12, 2025 | Substantially Equivalent |
| K252646 | Single-Use Fine Needle Biopsy (FNB) device (NA-U210H) | Oct 24, 2025 | Substantially Equivalent |
| K250945 | Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series) | Oct 17, 2025 | Substantially Equivalent |
| K251867 | EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (TJF-Q190V) | Sep 19, 2025 | Substantially Equivalent |
| K250862 | EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XP190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-P190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XT190); BRONCHOVIDEOSCOPE (OLYMPUS BF-H1100); BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH1100) | Jun 23, 2025 | Substantially Equivalent |
| K250701 | Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V) | Jun 5, 2025 | Substantially Equivalent |
| K250573 | Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q; Single Use 2-Lumen Cannula V PR-V614M | May 27, 2025 | Substantially Equivalent |