FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
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)
K Number: K251468
·
Decision Oct 3, 2025
Classifications
1
FEI Numbers
86
Registration Numbers
86
Same Product Code
81
Applicant Total
15
Review Days
143
Basic Information
- Device Name
- 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)
- K Number
- K251468
- 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
- May 13, 2025
- Decision Date
- October 3, 2025
- 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 | ||
|---|---|---|---|
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| 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 |