SpeediCath Compact Set
FDA 510(k) K200820 · Coloplast
510(k) numberK200820
Submission
- Device name
- SpeediCath Compact Set
- Applicant
- Coloplast
Plymouth, MN, US - Received
- March 30, 2020
- Decision date
- November 13, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GBM – Catheter, Urethral
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5130
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code GBM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241734 | Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic…GBM · Traditional | Well Lead Medical Co., Ltd. | 03/05/2025SE |
| K213283 | GentleCath Air for Men Hydrophilic Intermittent Urinary CatheterGBM · Traditional | Convatec Limited | 06/22/2022SE |
| K211436 | Intermittent Catheter (Not Finalized)GBM · Traditional | Hollister Incorporated | 01/27/2022SE |
| K192904 | SpeediCath Compact SetGBM · Traditional | Coloplast | 11/02/2020SE |
| K200142 | SpeediCath SoftGBM · Traditional | Coloplast | 07/30/2020SE |
| K200134 | Jimushi Sterile Urethral Catheter for single useGBM · Traditional | Hangzhou Jimushi Meditech Co., Ltd. | 06/01/2020SE |
| K191512 | LotusCatheter (Lotus No Balloon Catheter)GBM · Traditional | Hakki Medical Technologies, Inc. | 05/21/2020SESK |
| K192577 | Actreen Hi-Lite Intermittent Urinary CathetersGBM · Special | B.Braun Medical, Inc. | 05/07/2020SE |
| K193148 | VaPro Plus Pocket, VaPro PlusGBM · Special | Hollister Incorporated | 12/13/2019SE |
| K192468 | Male, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Femal, Nelaton-tip Ready-to-Use…GBM · Traditional | Hangzhou Bever Medical Devices Co., Ltd. | 11/27/2019SE |
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| K242173 | Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10…FED · Traditional | 11/12/2024SE |
| K242473 | Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551)…PAH · Traditional | 10/18/2024SE |
| K241028 | Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056)EZD · Traditional | 07/26/2024SE |
| K233411 | Folysil Silicone CatheterEZL · Traditional | 04/15/2024SE |
| K231953 | Biatain Fiber Ag (33570 - 5 cm x 5 cm / 2 in x 2 in); Biatain Fiber Ag (33572 - 10 cm x…FRO · Traditional | 03/22/2024SE |
Questions and answers
When was SpeediCath Compact Set cleared by the FDA?
SpeediCath Compact Set (K200820) received a 510(k) decision of Substantially Equivalent on November 13, 2020, 228 days after the submission was received.
What is the product code of K200820?
The FDA product code is GBM – Catheter, Urethral, a Class II (moderate risk) device regulated under 21 CFR 876.5130.