MANAN BONE MARROW BIOPSY NEEDLE— 510(k) K890925
Substantially EquivalentManan Medical Products, Inc.
FDA 510(k) clearance K890925 for MANAN BONE MARROW BIOPSY NEEDLE, Substantially Equivalent on 1989-04-11. Applicant: Manan Medical Products, Inc.. Device class: 1.
Clearance details
- Applicant
- Manan Medical Products, Inc.
- Product code
- Code DWO
- Device class
- Class 1
- Regulation
- 21 CFR 878.4800
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Northbrook, IL, US
Recent devices under product code DWO
view allMore clearances from Manan Medical Products, Inc.
view allRecalls naming K890925
K-number listed on FDA's recall record- Z-0814-2019 — "J" Type Bone Marrow Needle 11ga x 10 cm - Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration.
- Z-0815-2019 — J Type Bone Marrow Needle 13ga x 10 cm- Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration.
- Z-0816-2019 — J Type Bone Marrow Needle 13ga x 6cm - Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration.
- Z-0817-2019 — Double Diamond J Type Bone Marrow Needle & Marrow Extraction Cannula 11ga x 10cm 14MTWX x 12.5 cm
- Z-0818-2019 — Aguja de Aspiracion con Profundidad Ajustable Tipo I 16ga x 5 cm- Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration.
- Z-0819-2019 — Aguja para Biopsia Tipo Medula Osea Ergonomica 11ga x 10cm
- Z-0820-2019 — Aguja de Aspiration con Profundidad Ajustable Tipo I 15ga x 5 cm - Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K890925.
Data sourced from openFDA. This site is unofficial and independent of the FDA.