Retrieval Forceps
FDA 510(k) K820239 · American Endoscopy, Inc.
510(k) numberK820239
Submission
- Device name
- Retrieval Forceps
- Applicant
- American Endoscopy, Inc.
Mchenry, IL, US - Received
- January 29, 1982
- Decision date
- March 26, 1982
- 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
Other 510(k)s with product code KOD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K853274 | American Dilatation SystemKNQ · Traditional | 10/17/1985SE |
| K841384 | Proxima 1 PH MonitorFFT · Traditional | 07/19/1984SE |
| K833491 | Endo Bite BlockKTI · Traditional | 04/25/1984SE |
| K840818 | Biopsy ForcepsFCL · Traditional | 04/13/1984SE |
| K833859 | Tamponade Balloon CuffGCP · Traditional | 01/03/1984SE |
| K833492 | Percutaneous Endoscopic GastroscopyKNT · Traditional | 11/29/1983SE |
| K832458 | Automatic EndoscopeNVE · Traditional | 10/20/1983SE |
| K821818 | Retrieval BalloonsKOD · Traditional | 09/24/1982SE |
| K821819 | Pigtail StentsFGE · Traditional | 08/20/1982SE |
| K822062 | Ball Tip Coagulating ElectrodesGEI · Traditional | 08/19/1982SE |
Questions and answers
When was Retrieval Forceps cleared by the FDA?
Retrieval Forceps (K820239) received a 510(k) decision of Substantially Equivalent on March 26, 1982, 56 days after the submission was received.
What is the product code of K820239?
The FDA product code is KOD – Catheter, Urological, a Class II (moderate risk) device regulated under 21 CFR 876.5130.