FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
LOW PROFILE GASTROSTOMY FEEDING TUBE OR GASTROTOMEY BUTTON
K Number: K122030
·
Decision Sep 5, 2012
Classifications
1
FEI Numbers
228
Registration Numbers
229
Same Product Code
648
Applicant Total
19
Review Days
56
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- LOW PROFILE GASTROSTOMY FEEDING TUBE OR GASTROTOMEY BUTTON
- K Number
- K122030
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Degania Silicone , Ltd.
- Date Received
- July 11, 2012
- Decision Date
- September 5, 2012
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KNT), ordered by most recent decision date.
XNY Disposable Gastric Calibration Tube
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Flexi-Seal AIR (with ENFit Connector)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
hygh-tec Drainage II
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ZZIREN Orogastric Tube; ZZIREN SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN SGT Orogastric Tube - 36 Fr (ZZ-SGT-36); ZZIREN SGT Orogastric Tube - 40 Fr (ZZ-SGT-40); ZZIREN GBT Orogastric Tube - 32 Fr (ZZ-GBT-32); ZZIREN GBT Orogastric Tube - 36 Fr (ZZ-GBT-36); ZZIREN GBT Orogastric Tube - 40 Fr (ZZ-GBT-40)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Entarik NI Feeding Tube System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CORGRIP* SR NG/NI Tube Retention System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Degania Silicone , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K254170 | Percutaneous Endoscopic Gastrostomy (PEG) Kit | Mar 20, 2026 | Substantially Equivalent |
| K233591 | Stylus | May 31, 2024 | 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 |
| K103371 | COUDE/ OR TIEMANN | Mar 11, 2011 | Substantially Equivalent |
| K070124 | GASTROSTOMY REPLACEMENT TUBE, MODEL 253 | May 23, 2007 | Substantially Equivalent |