Personal Catheter
FDA 510(k) K970704 · Rochester Medical Corp.
510(k) numberK970704
Submission
- Device name
- Personal Catheter
- Applicant
- Rochester Medical Corp.
Stewartville, MN, US - Received
- February 26, 1997
- Decision date
- March 13, 1997
- 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 |
| K200820 | SpeediCath Compact SetGBM · Traditional | Coloplast | 11/13/2020SE |
| 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 |
More from Hollister Incorporated
| 510(k) | Device | Decision |
|---|---|---|
| K122785 | Hydrosil; Magic; Personal CatheterEZD · Traditional | 05/14/2013SE |
| K033477 | Hydrophilic-Antibacterial Intermittent Catheter, Intermittent Catheter Closed System KitMJC · Traditional | 06/10/2004SE |
| K001143 | Release NF Antibacterial Foley Catheter, Antibacterial Personal CatheterMJC · Traditional | 07/07/2000SE |
| K000723 | Hydrophilic Silicone Foley Catheter and Personal Catheter (Hydrophilic and…KOD · Traditional | 05/19/2000SE |
| K981612 | All Silicone Foley Catheter, Two-Way Foley Catheter, Three-Way Foley Catheter, Two-Way…EZL · Traditional | 07/08/1998SE |
| K971627 | Silicone Antibacterial Foley CatheterMJC · Traditional | 01/13/1998SE |
| K952082 | Rochester Medical Corporation Silicone Male External CatheterEXJ · Traditional | 07/18/1995SE |
| K941692 | Female Length All Silicone Urological CatheterEZL · Traditional | 03/06/1995SE |
| K943851 | All Silicone Intermittent CatheterGBM · Traditional | 01/31/1995SE |
| K923136 | Male External CatheterEXJ · Traditional | 12/03/1992SE |
Questions and answers
When was Personal Catheter cleared by the FDA?
Personal Catheter (K970704) received a 510(k) decision of Substantially Equivalent on March 13, 1997, 15 days after the submission was received.
What is the product code of K970704?
The FDA product code is GBM – Catheter, Urethral, a Class II (moderate risk) device regulated under 21 CFR 876.5130.