DeviceClearance

Product code KNW— Gastroenterology, Urology

VACUUM ASSISTED CORE BIOPSY DEVICE

Classification name
Instrument, Biopsy
Device class
Class 2
Regulation
21 CFR 876.1075
Advisory panel
Gastroenterology, Urology
Total cleared
365
First cleared
Most recent

Market context for product code KNW

FDA has cleared 365 devices under product code KNW between 1976 and 2026, filed by 178 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code KNW

Adverse 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 →

Recent clearances under product code KNW

1–100 of 365

Data sourced from openFDA. This site is unofficial and independent of the FDA.