Manan Prostatic Biopsy Needle
FDA 510(k) K895897 · Manan Medical Products, Inc.
510(k) numberK895897
Submission
- Device name
- Manan Prostatic Biopsy Needle
- Applicant
- Manan Medical Products, Inc.
Northbrook, IL, US - Received
- October 6, 1989
- Decision date
- October 18, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FCG – Biopsy Needle
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1075
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FCG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252646 | Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)FCG · Traditional | Olympus Medical Systems Corp. | 10/24/2025SE |
| K250994 | ClearTip FNA and FNB TypesFCG · Traditional | Finemedix Co., Ltd. | 08/21/2025SE |
| K241209 | EchoTip AcuCore EUS Biopsy Needle (ECHO-BX-19)FCG · Traditional | Cook Ireland, Ltd. | 07/29/2024SE |
| K231422 | Precision GIFCG · Traditional | Limaca Medical, Ltd. | 08/28/2023SE |
| K231267 | ClearTipFCG · Traditional | Finemedix Co., Ltd. | 06/30/2023SE |
| K230909 | EchoTip® AcuCore Ultrasound Biopsy Needle (ECHO-BX-3-22)FCG · Traditional | Cook Ireland, Ltd. | 05/30/2023SE |
| K212423 | EndoDrill® Model XFCG · Traditional | Bibbinstruments AB | 03/29/2023SE |
| K212822 | Disposable Coaxial Biopsy NeedleFCG · Traditional | Suzhou Leapmed Healthcare Corporation | 07/06/2022SE |
| K212819 | Disposable Biopsy Refill NeedleFCG · Traditional | Suzhou Leapmed Healthcare Corporation | 07/06/2022SE |
| K210476 | EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle…FCG · Traditional | Cook Ireland, Ltd. | 05/20/2021SE |
More from Cook Ireland, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K052802 | Manan Bio-Cut Soft Tissue Biopsy NeedleKNW · Special | 11/01/2005SE |
| K011209 | Manan Spritacre Spinal NeedlesBSP · Traditional | 06/26/2001SE |
| K983620 | Manan Spinal NeedlesBSP · Traditional | 01/08/1999SE |
| K980536 | Epidural NeedleBSP · Traditional | 07/31/1998SE |
| K981386 | Manan Blunt NeedleFPA · Traditional | 06/29/1998SE |
| K980211 | MRI Chiba,Spinal,Breast Localization,Automatic Cutting NeedlesKNW · Traditional | 02/06/1998SE |
| K974446 | Manan Automatic Cutting NeedleKNW · Traditional | 01/08/1998SE |
| K962977 | MRI Compatible Biopsy NeedlesKNW · Traditional | 10/09/1997SE |
| K963767 | Manan V.S. Access Needle/SetFGE · Traditional | 05/16/1997SE |
| K961986 | Manan D BagEXF · Traditional | 03/13/1997SE |
Questions and answers
When was Manan Prostatic Biopsy Needle cleared by the FDA?
Manan Prostatic Biopsy Needle (K895897) received a 510(k) decision of Substantially Equivalent on October 18, 1989, 12 days after the submission was received.
What is the product code of K895897?
The FDA product code is FCG – Biopsy Needle, a Class II (moderate risk) device regulated under 21 CFR 876.1075.