FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
KIT PAK URINARY CARE SUPPLIES
K Number: K925281
·
Decision Apr 19, 1993
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
63
Applicant Total
13
Review Days
181
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Basic Information
- Device Name
- KIT PAK URINARY CARE SUPPLIES
- K Number
- K925281
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5130
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Unknown
- Statement or Summary
- Statement
- Applicant
- Kit Pak, Inc.
- Date Received
- October 20, 1992
- Decision Date
- April 19, 1993
- Product Code
- KNY
- 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 |
|---|---|---|---|
| KNY | Accessories, Catheter, G-U | FDA class 2 | Gastroenterology, Urology |
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GUARDIAN URETHRAL SHEATH
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Kit Pak, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K942959 | KIT PAK WET SALINE DRESSING | Feb 14, 1995 | Substantially Equivalent for Some Indications |
| K941499 | KIT PAK DRESSING CHANGE TRAY | Jul 20, 1994 | Unknown |
| K932310 | KIT PAK INCONTINENT SKIN CARE KIT | Jun 1, 1994 | Unknown |
| K934080 | URINARY DRAINAGE BAG | May 18, 1994 | Substantially Equivalent |
| K931013 | FOLEY CATHETER TRAY | Aug 9, 1993 | Substantially Equivalent |
| K923905 | WOUND DRESSING KIT | Jul 2, 1993 | Unknown |
| K924051 | KIT PAK I.V. START KIT | Jun 22, 1993 | Unknown |
| K923906 | FOLEY INSERTION TRAY | Jun 22, 1993 | Unknown |
| K922051 | KIT PAK'S FLUSHING KIT | Jun 17, 1993 | Unknown |
| K900148 | KIT PAK IRRIGATION TRAY | Apr 23, 1990 | Unknown |