ORION MEDICAL INC. DISPOSABLE BRAIN BIOPSY NEEDLE FOR STEROTACTIC GUIDED BIOPSY— 510(k) K974158

Name: FDA 510(k) clearance K974158
Creator: U.S. Food and Drug Administration
Published: 1997-12-09

Substantially Equivalent

Ortho Development Corp.

FDA 510(k) clearance K974158 for ORION MEDICAL INC. DISPOSABLE BRAIN BIOPSY NEEDLE FOR STEROTACTIC GUIDED BIOPSY, Substantially Equivalent on 1997-12-09. Applicant: Ortho Development Corp.. Device class: 2.

Clearance details

Applicant: Ortho Development Corp.
Product code: Code KNW
Device class: Class 2
Regulation: 21 CFR 876.1075
Advisory panel: Gastroenterology, Urology
Date received: 1997-11-03
Decision date: 1997-12-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Draper, UT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KNW

view all

K260517 — Automatic Core Biopsy Instrument2026-08-28
K262571 — EnCor EnCompass Breast Biopsy and Tissue Removal System2026-08-14
K262792 — Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)2026-08-12
K260572 — Marrow Marxman2026-08-04
K261196 — Promisemed VeriEcto Automatic Biopsy Needles2026-05-12

More clearances from Ortho Development Corp.

view all

K253161 — Balanced Knee System TriMax Porous Femoral Components2025-12-19
K251052 — Trivicta® Hip Stem2025-05-22
K242984 — BKS Revision System2024-10-25
K242833 — Legend® Acetabular Shell2024-10-11
K233758 — Trivicta Hip Stem2024-03-08

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.