FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KIMBERLY-CLARK GASTROINTESTINAL ANCHOR SET WITH SAF-T-PEXY FASTENERS, ENTERNAL ACCESS DILATION SYSTEM
K Number: K093312
·
Decision Dec 8, 2009
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
25
Applicant Total
104
Review Days
47
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Basic Information
- Device Name
- KIMBERLY-CLARK GASTROINTESTINAL ANCHOR SET WITH SAF-T-PEXY FASTENERS, ENTERNAL ACCESS DILATION SYSTEM
- K Number
- K093312
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Kimberly-Clark Corp.
- Date Received
- October 22, 2009
- Decision Date
- December 8, 2009
- Product Code
- KGC
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KGC | Tube, Gastro-Enterostomy | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Kimberly-Clark Corp.
| K Number | Device Name | ||
|---|---|---|---|
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| K131879 | KC 300 SURGICAL MASK | Dec 20, 2013 | Substantially Equivalent |
| K131841 | KIMBERLY-CLARK LAVENDER NITRILE POWDER-FREE EXAM GLOVE | Nov 7, 2013 | Substantially Equivalent |
| K131254 | KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE | Aug 20, 2013 | Substantially Equivalent |
| K120985 | KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING | Dec 19, 2012 | Substantially Equivalent |
| K112805 | KIMGUARD ONE-STEP STERILIZATION WRAP | Jun 22, 2012 | Substantially Equivalent |
| K113423 | KIMBERLY CLARK PURPLE NITRILE, AND PURPLE NITRILE XTRA POWDER FREE EXAM GLOVE | Mar 9, 2012 | Substantially Equivalent |
| K112300 | KIMGUARD SMART-FOLD* STERILIZATION WRAP | Jan 19, 2012 | Substantially Equivalent |
| K112635 | U BY KOTEX SLEEK UNSCENTED MENSTRUAL TAMPONS | Oct 7, 2011 | Substantially Equivalent |