Coloplast Ostomy Rod, Model 12814
FDA 510(k) K052229 · Coloplast Corp.
510(k) numberK052229
Submission
- Device name
- Coloplast Ostomy Rod, Model 12814
- Applicant
- Coloplast Corp.
North Mankato, MN, US - Received
- August 16, 2005
- Decision date
- October 13, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- EZP – Rod, Colostomy
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4270
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code EZP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K040110 | Easy Loop, Model EZL-01EZP · Traditional | Tools For Surgery, LLC | 03/24/2004SE |
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Questions and answers
When was Coloplast Ostomy Rod, Model 12814 cleared by the FDA?
Coloplast Ostomy Rod, Model 12814 (K052229) received a 510(k) decision of Substantially Equivalent on October 13, 2006, 423 days after the submission was received.
What is the product code of K052229?
The FDA product code is EZP – Rod, Colostomy, a Class II (moderate risk) device regulated under 21 CFR 876.4270.