NEEDLE OR CUTTER— 510(k) K953399

Substantially Equivalent

Biophysic Medical, Inc.

FDA 510(k) clearance K953399 for NEEDLE OR CUTTER, Substantially Equivalent on 1995-10-30. Applicant: Biophysic Medical, Inc..

Clearance details

Applicant: Biophysic Medical, Inc.
Product code: Code KNW
Advisory panel: Gastroenterology, Urology
Date received: 1995-07-20
Decision date: 1995-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Juan Capistrano, CA, US

Download summary PDF View on FDA.gov ↗

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, 2020-01-01 through 2026-04-23. 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.