Fusion OMNI Sphincterotome— 510(k) K172288
Substantially EquivalentWilson-Cook Medical Inc./Cook Endoscopy
FDA 510(k) clearance K172288 for Fusion OMNI Sphincterotome, Substantially Equivalent on 2018-04-17. Applicant: Wilson-Cook Medical Inc./Cook Endoscopy. Device class: 2.
Clearance details
- Applicant
- Wilson-Cook Medical Inc./Cook Endoscopy
- 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
- Winston-Salem, NC, US
Recent devices under product code KNS
view allMore clearances from Wilson-Cook Medical Inc./Cook Endoscopy
view all- K190829 — Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI)
- K172665 — Classic Cotton Cannulatome®, CannulaTome II® Double Lumen Sphincterotome, Cotton CannulaTome II® PC, UTS® Ultra Taper Sphincterotome, Tri-Tome pc® Triple Lumen Sphincterotome, Howell D.A.S.H.® Sphincterotome with DomeTip®, Billroth II Sphincterotome, Soehendra® BII Sphincterotome, Models ACU-1 and ACU-1-VL active cords
- K171993 — Zimmon Needle Knife Papillotome
- K171607 — Bronchi and Gastrointestinal Cytology Brush
- K121505 — DISPOSABLE HEMOSTASIS CHIP
Adverse 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.