SINGLE USE PRELOADED SPHINCTEROTOME V (DISTAL WIREGUIDED); SINGLE USE SP— 510(k) K141991
Substantially EquivalentOlympus Medical Systems Copr.
FDA 510(k) clearance K141991 for SINGLE USE PRELOADED SPHINCTEROTOME V (DISTAL WIREGUIDED); SINGLE USE SP, Substantially Equivalent on 2015-03-31. Applicant: Olympus Medical Systems Copr.. Device class: 2.
Clearance details
- Applicant
- Olympus Medical Systems Copr.
- Product code
- Code KNS
- Device class
- Class 2
- Regulation
- 21 CFR 876.4300
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Center Valley, PA, US
Recent devices under product code KNS
view allAdverse events under product code KNS
product code KNS- Death
- 44
- Injury
- 2,361
- Malfunction
- 4,771
- Total
- 7,176
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 →
Recalls naming K141991
K-number listed on FDA's recall record- Z-1278-2026 — Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0720; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
- Z-1279-2026 — Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0730; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
- Z-1297-2026 — Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0725; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K141991.
Data sourced from openFDA. This site is unofficial and independent of the FDA.