Prepacell Thin Needle Aspiration Tray
FDA 510(k) K833719 · Applied Medical Devices, Inc.
510(k) numberK833719
Submission
- Device name
- Prepacell Thin Needle Aspiration Tray
- Applicant
- Applied Medical Devices, Inc.
Mchenry, IL, US - Received
- October 24, 1983
- Decision date
- January 25, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KOD – Catheter, Urological
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5130
- Specialty
- Gastroenterology, Urology
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|---|---|---|---|
| K251864 | Rubber Utility CatheterKOD · Traditional | C.R. Bard, Inc. | 02/23/2026SE |
| K220036 | Wellead Ureteral CatheterKOD · Traditional | Well Lead Medical Co., Ltd. | 12/16/2022SE |
| K220730 | allFlex Ureteral Catheters, Krait Ureteral CathetersKOD · Traditional | Allwin Medical Devices, Inc. | 10/13/2022SE |
| K211032 | Urinary Catheter 12 Fr, Urinary Catheter 16 FrKOD · Traditional | Urogen Pharma, Ltd. | 11/19/2021SE |
| K181979 | Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent CatheterKOD · Traditional | Teleflexmedical, Inc. | 05/24/2019SE |
| K180354 | UroGen Ureteral CatheterKOD · Traditional | Urogen Pharma, Ltd. | 10/30/2018SE |
| K181144 | Angled Tip Ureteral CatheterKOD · Traditional | Cook Incorporated | 06/28/2018SE |
| K180530 | Imager II Urology Torque CatheterKOD · Special | Boston Scientific Corporation | 04/10/2018SE |
| K171810 | Cone Tip Ureteral Catheter, Rutner Universal Wedge CatheterKOD · Traditional | Cook Incorporated | 03/07/2018SE |
| K171600 | Renal Access Cobra Catheter, Kumpe Access CatheterKOD · Traditional | Cook Incorporated | 02/16/2018SE |
More from Cook Incorporated
| 510(k) | Device | Decision |
|---|---|---|
| K843885 | Percutaneous Aspiration Biopsy Tray · Traditional | 12/19/1984SE |
| K843884 | General Utility Tray System · Traditional | 12/13/1984SE |
| K843883 | Sterile Percutaneous Transhepatic Cholan · Traditional | 12/13/1984SE |
| K840904 | Accu-Cult Fecal Occult Blood TestKHE · Traditional | 08/16/1984SE |
| K842591 | Ultrasound Probe Covers-SterileIYO · Traditional | 07/23/1984SE |
| K833720 | Transthoracic/Transabdominal-TrayGDM · Traditional | 05/30/1984SE |
| K840334 | Chemonucleolysis/Discography TrayFMI · Traditional | 04/13/1984SE |
| K833438 | Prepacell-Sterile-Bone Marrow AspirKDD · Traditional | 02/09/1984SE |
| K802406 | Cytotran I Bone Marrow Aspiration SystemFMF · Traditional | 01/15/1981SE |
| K791660 | Prepacell-Bone Marrow SamplerFMF · Traditional | 09/12/1979SE |
Questions and answers
When was Prepacell Thin Needle Aspiration Tray cleared by the FDA?
Prepacell Thin Needle Aspiration Tray (K833719) received a 510(k) decision of Substantially Equivalent on January 25, 1984, 93 days after the submission was received.
What is the product code of K833719?
The FDA product code is KOD – Catheter, Urological, a Class II (moderate risk) device regulated under 21 CFR 876.5130.