FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
URETHRAL CATHETERIZATION TRAYS
K Number: K896212
·
Decision Jan 24, 1990
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
59
Applicant Total
28
Review Days
90
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Basic Information
- Device Name
- URETHRAL CATHETERIZATION TRAYS
- K Number
- K896212
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5130
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Unknown
- Applicant
- Westmark, Sterile Packing Systems, Inc. (Sps)
- Date Received
- October 26, 1989
- Decision Date
- January 24, 1990
- Product Code
- FCM
- 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 |
|---|---|---|---|
| FCM | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Westmark, Sterile Packing Systems, Inc. (Sps)
| K Number | Device Name | ||
|---|---|---|---|
| K896800 | IRRIGATION TRAY | May 24, 1990 | Unknown |
| K896799 | PARACERVICAL/PUDENDAL TRAYS | Apr 23, 1990 | Substantially Equivalent |
| K896559 | INFANT FEEDING TUBE | Mar 13, 1990 | Substantially Equivalent |
| K896794 | SPECIMEN CONTAINER | Mar 1, 1990 | Substantially Equivalent |
| K896806 | CATHETER PLUG/PROTECTOR | Feb 26, 1990 | Substantially Equivalent |
| K896798 | TRACHEOSTOMY TRAY | Feb 22, 1990 | Substantially Equivalent |
| K896797 | SUCTION CATHETER KIT | Feb 16, 1990 | Substantially Equivalent |
| K896215 | MERCY HIP/KNEE PACK | Feb 13, 1990 | Substantially Equivalent |
| K896804 | MANIFOLD | Feb 8, 1990 | Substantially Equivalent |
| K896556 | UNIVERSAL POOLE SUCTION TUBE | Feb 6, 1990 | Substantially Equivalent |