FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
STERILE URETHRAL CATHETER PROCEDURE KITS
K Number: K903340
·
Decision Oct 4, 1990
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
59
Applicant Total
14
Review Days
71
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Basic Information
- Device Name
- STERILE URETHRAL CATHETER PROCEDURE KITS
- K Number
- K903340
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5130
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Unknown
- Applicant
- Superior Healthcare Group, Inc.
- Date Received
- July 25, 1990
- Decision Date
- October 4, 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 Superior Healthcare Group, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K925530 | INSTRUMENT WARMER | Jun 18, 1993 | Substantially Equivalent |
| K924764 | OVERTUBE FOR ENDSCOPIC LIGATOR | Mar 15, 1993 | Substantially Equivalent |
| K905755 | NON-STERILE PATIENT EXAMINATION GLOVES | Mar 8, 1991 | Substantially Equivalent |
| K903347 | SODIUM CHLORIDE SOLUTION | Dec 13, 1990 | Substantially Equivalent |
| K904216 | STERILE WATER SOLUTION CATALOG # 10000 | Nov 16, 1990 | Substantially Equivalent |
| K896321 | NO. 34100 - 8 FR & NO. 34400 - 14 FR CLOSED TRACH. | Nov 13, 1989 | Substantially Equivalent |
| K894676 | STERILE LATEX EXAM GLOVES | Aug 17, 1989 | Substantially Equivalent |
| K891445 | LATEX EXAMINATION GLOVES | Aug 9, 1989 | Substantially Equivalent |
| K892426 | NO. 86500 - ENDOSCOPIC JET WASHER | Jun 22, 1989 | Substantially Equivalent |
| K885339 | FLOW THRU 16,18,20,22 FR REPLACE. GASTRO TUBE KIT | Mar 1, 1989 | Substantially Equivalent |