EnCor EnCompass Breast Biopsy and Tissue Removal System— 510(k) K262571
Substantially EquivalentBard Peripheral Vascular, Inc.
FDA 510(k) clearance K262571 for EnCor EnCompass Breast Biopsy and Tissue Removal System, Substantially Equivalent on 2026-08-14. Applicant: Bard Peripheral Vascular, Inc.. Device class: 2.
Summary
Bard Peripheral Vascular's EnCor EnCompass Breast Biopsy and Tissue Removal System is filed under product code KNW, biopsy instruments. The record gives no model numbers.
Class II, 21 CFR 876.1075. The General and Plastic Surgery review panel handled it as a Special 510(k), though the record lists Gastroenterology and Urology as the classification panel.
Bard filed from Tempe, Arizona. The decision came 21 calendar days after receipt (July 24 to August 14, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Bard Peripheral Vascular, Inc.
- Product code
- Product code KNW
- Device class
- Class 2
- Regulation
- 21 CFR 876.1075
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Tempe, AZ, US
Recent devices under product code KNW
view allMore clearances from Bard Peripheral Vascular, Inc.
view allAdverse events under product code KNW
product code KNW- Death
- 9
- Injury
- 965
- Malfunction
- 10,444
- Other
- 3
- Total
- 11,421
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.