Bauer Temno Biopsy Needle
FDA 510(k) K902319 · Proact, Ltd.
510(k) numberK902319
Submission
- Device name
- Bauer Temno Biopsy Needle
- Applicant
- Proact, Ltd.
State College, PA, US - Received
- May 23, 1990
- Decision date
- September 6, 1990
- 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 |
|---|---|---|
| K052243 | Proact with Gel or Proact 1JOW · Traditional | 04/12/2006SE |
| K003909 | Proact 1IRP · Traditional | 06/13/2001SE |
| K941256 | Quick Core IIKNW · Traditional | 07/13/1994SE |
| K926559 | Proact Biopsy Needle EnchancementsFCG · Traditional | 03/22/1993SE |
| K913306 | Bone-Temno/Sternum-TemnoLWE · Traditional | 11/01/1991SE |
| K902320 | Bauer Flexi-Temno Biopsy NeedleFCG · Traditional | 10/01/1990SE |
Questions and answers
When was Bauer Temno Biopsy Needle cleared by the FDA?
Bauer Temno Biopsy Needle (K902319) received a 510(k) decision of Substantially Equivalent on September 6, 1990, 106 days after the submission was received.
What is the product code of K902319?
The FDA product code is FCG – Biopsy Needle, a Class II (moderate risk) device regulated under 21 CFR 876.1075.