FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
Stylus
K Number: K233591
·
Decision May 31, 2024
Classifications
1
FEI Numbers
228
Registration Numbers
229
Same Product Code
648
Applicant Total
19
Review Days
205
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Basic Information
- Device Name
- Stylus
- K Number
- K233591
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Degania Silicone , Ltd.
- Date Received
- November 8, 2023
- Decision Date
- May 31, 2024
- Product Code
- KNT
- 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 |
|---|---|---|---|
| KNT | Tubes, Gastrointestinal (And Accessories) | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Degania Silicone , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K254170 | Percutaneous Endoscopic Gastrostomy (PEG) Kit | Mar 20, 2026 | Substantially Equivalent |
| K152246 | Aquarius Stoma Measuring Device | Jun 21, 2016 | Substantially Equivalent |
| K143378 | AQUARIUS Gastrostomy Replacement Tube | Dec 29, 2014 | Substantially Equivalent |
| K141753 | AQUARIUS NASAL FEEDING TUBE | Oct 16, 2014 | Substantially Equivalent |
| K141631 | AQUARIUS EXTENSION FEEDING SET | Jul 28, 2014 | Unknown |
| K132686 | AQUARIUS LOW PROFILE GASTROSTOMY FEEDING TUBE | May 12, 2014 | Unknown |
| K131020 | TEMPERATURE SENSOR CATHETER | May 9, 2013 | Substantially Equivalent |
| K122030 | LOW PROFILE GASTROSTOMY FEEDING TUBE OR GASTROTOMEY BUTTON | Sep 5, 2012 | Substantially Equivalent |
| K103371 | COUDE/ OR TIEMANN | Mar 11, 2011 | Substantially Equivalent |
| K070124 | GASTROSTOMY REPLACEMENT TUBE, MODEL 253 | May 23, 2007 | Substantially Equivalent |