FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GIENTRIPORT WITH UNIVERSAL SINGLE LUMEN ADAPTOR
K Number: K053410
·
Decision Jan 6, 2006
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
12
Applicant Total
12
Review Days
30
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Basic Information
- Device Name
- GIENTRIPORT WITH UNIVERSAL SINGLE LUMEN ADAPTOR
- K Number
- K053410
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Kendall
- Date Received
- December 7, 2005
- Decision Date
- January 6, 2006
- Product Code
- FEG
- 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 |
|---|---|---|---|
| FEG | Tube, Double Lumen For Intestinal Decompression And/Or Intubation | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Kendall
| K Number | Device Name | ||
|---|---|---|---|
| K092797 | ACUTE AND CHRONIC CATHETER REPAIR KIT | Nov 19, 2009 | Unknown |
| K062671 | 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING AND SILVER IMPREGNATED SLEEVE (PALINDROME SAPPHIRE) | Nov 3, 2006 | Unknown |
| K060972 | KEDALL 14.5 FR CHRONIC HEMODIALYSIS CATHETER W/SILVER IMPREGNATED SLEEVE (PALINDROME RUBY) | Aug 4, 2006 | Substantially Equivalent |
| K051584 | 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH INSERTION STYLETS ACCESSORY | Oct 6, 2005 | Substantially Equivalent |
| K043272 | PALLINDROME 14.5FR CHRONIC HEMODIALYSIS CATHETER WITH SLOTTED SYMMETRICAL TIP | Dec 22, 2004 | Substantially Equivalent |
| K042461 | KENDALL ARGYLE 2 FR DOUBLE LUMEN NEONATAL/PEDIATRIC PICC, MODEL 43304 | Dec 10, 2004 | Substantially Equivalent |
| K042572 | KENDALL CO2NFIRM NOW CO2 DETECTOR | Nov 5, 2004 | Substantially Equivalent |
| K041914 | PALLINDROME 14.5FR CHRONIC HEMODIALYSIS CATHETER | Sep 27, 2004 | Substantially Equivalent |
| K041006 | TANDEM-CATH HEMODIALYSIS CATHETER, MODEL 10 FR | May 19, 2004 | Substantially Equivalent |
| K040388 | NEXT GENERATION SALEM SUMP | May 17, 2004 | Substantially Equivalent |