Rotex Screw Biopsy Needle
FDA 510(k) K854404 · Meadox Surgimed, Inc.
510(k) numberK854404
Submission
- Device name
- Rotex Screw Biopsy Needle
- Applicant
- Meadox Surgimed, Inc.
Oakland, NJ, US - Received
- November 1, 1985
- Decision date
- December 2, 1985
- 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 |
|---|---|---|
| K944143 | MS Classique Balloon CatheterFGE · Traditional | 03/13/1995SE |
| K945061 | Noprofile Olbert Catheter SystemKOD · Traditional | 03/09/1995SE |
| K942382 | MS Amplatz Extra Stiff Guide WireDQX · Traditional | 08/22/1994SE |
| K930201 | Acecut Sutomatic Biopsy SystemKNW · Traditional | 06/09/1993SE |
| K911635 | Meadox(R) Surgimed(R) Biopsy Gun IIKNW · Traditional | 06/20/1991SE |
| K905181 | No Profile Olbert Catheter System for UrologyEZN · Traditional | 03/06/1991SE |
| K904582 | Quickwire - Hydrophilic Coated GuidewireDQX · Traditional | 02/25/1991SE |
| K904983 | Meadox(R) Surgimed Olbert Cath Syst for UrologyEZN · Traditional | 01/30/1991SE |
| K902461 | Meadox Surgimed Biopsy Gun and NeedleKNW · Traditional | 07/16/1990SE |
| K890926 | Surecut BMB Bone Marrow Biopsy/Aspiration NeedleFMI · Traditional | 06/20/1989SE |
Questions and answers
When was Rotex Screw Biopsy Needle cleared by the FDA?
Rotex Screw Biopsy Needle (K854404) received a 510(k) decision of Substantially Equivalent on December 2, 1985, 31 days after the submission was received.
What is the product code of K854404?
The FDA product code is FCG – Biopsy Needle, a Class II (moderate risk) device regulated under 21 CFR 876.1075.