Instinct Plus Endoscopic Clipping Device— 510(k) K212323
Substantially EquivalentWilson-Cook Medical, Inc.
FDA 510(k) clearance K212323 for Instinct Plus Endoscopic Clipping Device, Substantially Equivalent on 2021-08-25. Applicant: Wilson-Cook Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Wilson-Cook Medical, Inc.
- Product code
- Code PKL
- Device class
- Class 2
- Regulation
- 21 CFR 876.4400
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Winston-Salem, NC, US
Recent devices under product code PKL
view allMore clearances from Wilson-Cook Medical, Inc.
view allAdverse events under product code PKL
product code PKL- Death
- 9
- Injury
- 489
- Malfunction
- 4,698
- Other
- 1
- Total
- 5,197
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 K212323
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K212323.
Data sourced from openFDA. This site is unofficial and independent of the FDA.