FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
URINARY DIVERSION EVACUATING CATHETER
K Number: K914692
·
Decision Jul 2, 1992
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
11
Applicant Total
104
Review Days
258
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Basic Information
- Device Name
- URINARY DIVERSION EVACUATING CATHETER
- K Number
- K914692
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5895
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Cook Urological, Inc.
- Date Received
- October 18, 1991
- Decision Date
- July 2, 1992
- Product Code
- EXD
- 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 |
|---|---|---|---|
| EXD | Irrigator, Ostomy | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EXD), ordered by most recent decision date.
OSTOMY IRRIGATION SET
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PALEX IRRIGATION SET
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IRRIGATION SYSTEM
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VISI-FLOW IRRIGATOR
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UNI-TIP COLOSTOMY IRRIGATION CONE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Cook Urological, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K102141 | COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED) | May 6, 2011 | Substantially Equivalent |
| K091767 | 3 WAY SILICONE FOLEY BALLOON CATHETER | Oct 9, 2009 | Substantially Equivalent |
| K082939 | COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400 | Sep 3, 2009 | Substantially Equivalent |
| K082066 | TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLER | Nov 7, 2008 | Substantially Equivalent |
| K082536 | COOK WIRE GUIDES | Oct 27, 2008 | Substantially Equivalent |
| K082319 | INJEKT FILIFORM INJECTION NEEDLE | Sep 25, 2008 | Substantially Equivalent |
| K080525 | COOK ODYSSEY HOLMIUM LASER SYSTEM, MODEL 30W | Apr 17, 2008 | Substantially Equivalent |
| K073496 | OPTILITE HOLMIUM LASER FIBERS | Jan 23, 2008 | Substantially Equivalent |
| K072521 | COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH | Nov 20, 2007 | Substantially Equivalent |
| K061371 | SYDNEY IVF SPERM CRYOPRESERVATION BUFFER | Aug 17, 2006 | Substantially Equivalent |