Opticon Direct Male Urinary Catheter for Continuous Drainage
FDA 510(k) K970716 · Opticon Medical, Inc.
510(k) numberK970716
Submission
- Device name
- Opticon Direct Male Urinary Catheter for Continuous Drainage
- Applicant
- Opticon Medical, Inc.
Minneapolis, MN, US - Received
- February 27, 1997
- Decision date
- May 16, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- EZL – Catheter, Retention Type, Balloon
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5130
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code EZL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260756 | TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221)EZL · Traditional | Sentinel Medical Technologies, | 09/04/2026SE |
| K262056 | Rusch Latex Gold Foley CatheterEZL · Traditional | Teleflex Medical Sdn. Bhd. | 08/05/2026SE |
| K252537 | Rusch SoftSimplastic Foley CathetersEZL · Traditional | Teleflex Medical Sdn. Bhd. | 01/20/2026SE |
| K243011 | Silicone Urethral Catheter (Silicone Urethral Catheter)EZL · Traditional | Guangdong Ecan Medical Co., Ltd. | 06/16/2025SE |
| K241424 | InnoCare Specialty Foley CatheterEZL · Traditional | Innocare Urologics, LLC | 09/18/2024SE |
| K232469 | Rüsch Latex Gold Foley CatheterEZL · Traditional | Teleflexmedical, Inc. | 08/01/2024SE |
| K240057 | TraumaGuard Intra-abdominal Pressure Sensing SystemEZL · Traditional | Sentinel Medical Technologies, LLC | 04/17/2024SE |
| K233411 | Folysil Silicone CatheterEZL · Traditional | Coloplast Corp. | 04/15/2024SE |
| K233013 | 2-Way 100% Silicone Cleartract CatheterEZL · Traditional | Silq Technologies Corporation | 01/23/2024SE |
| K212077 | Teleflex Rusch SoftSimplastic Foley CathetersEZL · Traditional | Teleflexmedical, Inc. | 07/27/2023SE |
More from Teleflexmedical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K041983 | Option-Vm Urinary Catheter/Adpater, Models MV39016, MVA39016EZL · Traditional | 11/17/2004SE |
| K033830 | Option-Vf Urinary Catheter with Adaptor, Model FVA14218; Option-V Continuous Drainage…EZL · Special | 01/09/2004SE |
| K023090 | Option-Vf Urinary Catheter, FV14218EZL · Traditional | 03/19/2003SE |
| K930194 | Hemostasis Valve and Tubing SetDYB · Traditional | 09/22/1993SE |
| K904999 | Weingarten TM Capnographic Intubation StyletteBSR · Traditional | 01/26/1993SE |
| K895955 | Loper Celiac Plexus Block Catheter KitCAZ · Traditional | 02/22/1990SE |
| K895476 | Option Epidural CathetersCAZ · Traditional | 01/19/1990SE |
Questions and answers
When was Opticon Direct Male Urinary Catheter for Continuous Drainage cleared by the FDA?
Opticon Direct Male Urinary Catheter for Continuous Drainage (K970716) received a 510(k) decision of Substantially Equivalent on May 16, 1997, 78 days after the submission was received.
What is the product code of K970716?
The FDA product code is EZL – Catheter, Retention Type, Balloon, a Class II (moderate risk) device regulated under 21 CFR 876.5130.