PerfIC Cath Gel S, PerfIC Cath Gel C, PerfIC Cath Hydro S, PerfIC Cath Hydro C
FDA 510(k) K161445 · Adapta Medical, Inc.
510(k) numberK161445
Submission
- Device name
- PerfIC Cath Gel S, PerfIC Cath Gel C, PerfIC Cath Hydro S, PerfIC Cath Hydro C
- Applicant
- Adapta Medical, Inc.
Colorado Springs, CO, US - Received
- May 25, 2016
- Decision date
- August 16, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- EZD – Catheter, Straight
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5130
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code EZD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260737 | Cure Aqua Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure…EZD · Traditional | Convatec | 08/05/2026SE |
| K261658 | LoFric Origo Pro CoudéEZD · Special | Wellspect AB | 07/17/2026SE |
| K262045 | Luja SoftEZD · Special | Coloplast A.S. | 07/07/2026SE |
| K260394 | Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR)EZD · Traditional | Hangzhou Jimushi Meditech Co., Ltd. | 06/24/2026SE |
| K253295 | Coude Sleeved IC; Coude Plus Sleeved ICEZD · Traditional | Hollister Incorporated | 05/18/2026SE |
| K260999 | LoFric Elle ProEZD · Special | Wellspect AB | 04/24/2026SE |
| K252943 | GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for WomenEZD · Traditional | Convatec Limited | 04/01/2026SE |
| K260502 | Liv Pre-lubricated Intermittent CatheterEZD · Traditional | HR Healthcare | 03/12/2026SE |
| K251274 | EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic…EZD · Traditional | HR Healthcare | 01/29/2026SESK |
| K251178 | Ready to use Nelaton CatheterEZD · Traditional | Jamjoom Fullcare Corporation | 01/02/2026SE |
More from Jamjoom Fullcare Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K103043 | Colorado Catheter Sterilesure - New Name Perfic CathEZD · Traditional | 01/07/2011SE |
Questions and answers
When was PerfIC Cath Gel S, PerfIC Cath Gel C, PerfIC Cath Hydro S, PerfIC Cath Hydro C cleared by the FDA?
PerfIC Cath Gel S, PerfIC Cath Gel C, PerfIC Cath Hydro S, PerfIC Cath Hydro C (K161445) received a 510(k) decision of Substantially Equivalent on August 16, 2016, 83 days after the submission was received.
What is the product code of K161445?
The FDA product code is EZD – Catheter, Straight, a Class II (moderate risk) device regulated under 21 CFR 876.5130.