Bip Biopsy Needle Modification
FDA 510(k) K934370 · Bip USA, Inc.
510(k) numberK934370
Submission
- Device name
- Bip Biopsy Needle Modification
- Applicant
- Bip USA, Inc.
Niagara Falls, NY, US - Received
- September 7, 1993
- Decision date
- March 7, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
|---|---|---|
| K024089 | Vacuflash Biopsy SystemKNW · Traditional | 03/11/2003SE |
| K934371 | Bip Multi ModificationKNW · Traditional | 04/28/1994SE |
| K935457 | Localization Wire or Marker - SurgicalGDF · Traditional | 02/17/1994SE |
| K925870 | SpacerMJG · Traditional | 05/19/1993SE |
| K925875 | Horizontal Needle Guide AttachmentGDF · Traditional | 04/06/1993SE |
| K925874 | Breast StabilizerMDM · Traditional | 03/16/1993SE |
Questions and answers
When was Bip Biopsy Needle Modification cleared by the FDA?
Bip Biopsy Needle Modification (K934370) received a 510(k) decision of Substantially Equivalent on March 7, 1994, 181 days after the submission was received.
What is the product code of K934370?
The FDA product code is FCG – Biopsy Needle, a Class II (moderate risk) device regulated under 21 CFR 876.1075.