Adt Percutaneous Transhepatic Disp. Chol
FDA 510(k) K800419 · A.D.T. Lab Industries
510(k) numberK800419
Submission
- Device name
- Adt Percutaneous Transhepatic Disp. Chol
- Applicant
- A.D.T. Lab Industries
Mchenry, IL, US - Received
- February 26, 1980
- Decision date
- March 25, 1980
- 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K812297 | A.D.T. Procedures TrayKMJ · Traditional | 09/28/1981SE |
| K801754 | Adt Bone Marrow Aspiration NeedleGAA · Traditional | 08/20/1980SE |
| K801753 | Adt Bone Marrow Biopsy-Aspir. NeeldeGAA · Traditional | 08/20/1980SE |
| K800418 | Adt Disposable Thin Needle AspirationFSM · Traditional | 04/28/1980SE |
| K800417 | Adt PTC Pro. Tray W/(Skinny Chiba) NeedlGAA · Traditional | 04/28/1980SE |
| K800414 | Adt Soft Tissue Biopsy TrayGAA · Traditional | 04/28/1980SE |
| K800412 | Rosenthal Needle (Disp.) Adt Bone MarrowGAA · Traditional | 04/28/1980SE |
| K800411 | Aspiration Tray W/Ferris Disp. IllinoisGAA · Traditional | 04/28/1980SE |
| K800410 | Adt Bone Marrow Biopsy-Aspiration TrayGAA · Traditional | 04/28/1980SE |
| K800409 | Adt Bone Marrow Biopsy Aspiration TrayGAA · Traditional | 04/28/1980SE |
Questions and answers
When was Adt Percutaneous Transhepatic Disp. Chol cleared by the FDA?
Adt Percutaneous Transhepatic Disp. Chol (K800419) received a 510(k) decision of Substantially Equivalent on March 25, 1980, 28 days after the submission was received.
What is the product code of K800419?
The FDA product code is FCG – Biopsy Needle, a Class II (moderate risk) device regulated under 21 CFR 876.1075.