BONE-TEMNO/STERNUM-TEMNO— 510(k) K913306
Substantially EquivalentProact, Ltd.
FDA 510(k) clearance K913306 for BONE-TEMNO/STERNUM-TEMNO, Substantially Equivalent on 1991-11-01. Applicant: Proact, Ltd.. Device class: 2.
Clearance details
- Applicant
- Proact, Ltd.
- Product code
- Code LWE
- Device class
- Class 2
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- State College, PA, US
Recent devices under product code LWE
view allMore clearances from Proact, Ltd.
view allRecalls naming K913306
K-number listed on FDA's recall record- Z-0154-2022 — Catalog # BEK3411, Ecomomy Jamshidi Bone Marrow Biopsy Tray, 11 G X 4"Biopsy/Aspiration needle, sterile, Qty: 10, Single Use Only, RX only. Exp. Date Lidocaine Vendor lot. CareFusion Intended use to aspirate marrow from either the sternum or the iliac crest. Intraosseous Infusion is recommended only in life-threatening emergencies where vascular access is critical and conventional forms of access are not available or are unobtainable.
- Z-1423-2018 — ILLINOIS (TJ) NEEDLE ASPIRATION [15GA, 18GA]; STERILE;
- Z-1424-2018 — JAMSHIDI (TJ) NEEDLE BONE MARROW [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 4, d.) 8G x 6, e.) 11G x 6]; STERILE;
- Z-1425-2018 — JAMSHIDI (TJ) NEEDLE BM ASP MAC [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 3.5, d.) 8G x 6, e.) 11G x 6]; STERILE;
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K913306.
Data sourced from openFDA. This site is unofficial and independent of the FDA.