Hypodermic Needles, Single Lumen
FDA 510(k) K911397 · Popper & Sons, Inc.
510(k) numberK911397
Submission
- Device name
- Hypodermic Needles, Single Lumen
- Applicant
- Popper & Sons, Inc.
New Hyde Park, NY, US - Received
- March 29, 1991
- Decision date
- May 20, 1991
- 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 |
|---|---|---|
| K843830 | J -Jamshidi Type-Bone Marrow Biopsy/AspiGDM · Traditional | 10/26/1984SE |
| K843690 | Illinois Sternum/Iliac Aspiration NeedleGDM · Traditional | 10/25/1984SE |
| K842406 | Wescott Type Biopsy Needle · Traditional | 08/09/1984SE |
| K841301 | Gardner Type Bone Marrow NeedleGAA · Traditional | 06/05/1984SE |
| K841300 | Antrum Needle-Wolf Type · Traditional | 06/05/1984SE |
| K841299 | Bierman Biopsy NeedleGDM · Traditional | 05/02/1984SE |
| K840168 | Westerman-Jensen Biopsy NeedleFCG · Traditional | 03/12/1984SE |
Questions and answers
When was Hypodermic Needles, Single Lumen cleared by the FDA?
Hypodermic Needles, Single Lumen (K911397) received a 510(k) decision of Substantially Equivalent on May 20, 1991, 52 days after the submission was received.
What is the product code of K911397?
The FDA product code is FCG – Biopsy Needle, a Class II (moderate risk) device regulated under 21 CFR 876.1075.