FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Coude Sleeved IC; Coude Plus Sleeved IC
K Number: K253295
·
Decision May 18, 2026
Classifications
1
FEI Numbers
86
Registration Numbers
86
Same Product Code
81
Applicant Total
15
Review Days
231
Basic Information
- Device Name
- Coude Sleeved IC; Coude Plus Sleeved IC
- K Number
- K253295
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5130
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hollister Incorporated
- Date Received
- September 29, 2025
- Decision Date
- May 18, 2026
- Product Code
- EZD
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| EZD | Catheter, Straight | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Hollister Incorporated
| K Number | Device Name | ||
|---|---|---|---|
| K251468 | Sleeved IC 3 Family Sleeved IC 3 SWT (name not finalized) Sleeved IC 3 Pocket (name not finalized) Sleeved IC 3 Plus (name not finalized) Sleeved IC 3 Plus Pocket (name not finalized) (N/A) | Oct 3, 2025 | Substantially Equivalent |
| K233524 | Sleeved IC 2 Family; Sleeved IC 2 SWT (Name not Finalized); Sleeved IC 2 Plus (Name not Finalized); Sleeved IC 2 Pocket (Name not Finalized); Sleeved IC 2 Plus Pocket (Name not Finalized) | May 3, 2024 | Substantially Equivalent |
| K220667 | Sleeved IC | Dec 8, 2022 | Substantially Equivalent |
| K213575 | Female IC (Not Finalized) | Sep 13, 2022 | Substantially Equivalent |
| K211436 | Intermittent Catheter (Not Finalized) | Jan 27, 2022 | Substantially Equivalent |
| K193148 | VaPro Plus Pocket, VaPro Plus | Dec 13, 2019 | Substantially Equivalent |
| K191633 | Infyna Chic | Jul 19, 2019 | Substantially Equivalent |
| K183253 | ValPro 2 Plus, VaPro 2 Plus Pocket | Dec 18, 2018 | Substantially Equivalent |
| K180824 | VaPro 2 Intermittent Catheter | Jun 22, 2018 | Substantially Equivalent |
| K163179 | Onli Intermittent Catheter | Jan 26, 2017 | Substantially Equivalent |