FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CATHETERIZATION PROCED. TRAY, URETHRAL
K Number: K780124
·
Decision Feb 21, 1978
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
59
Applicant Total
11
Review Days
28
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Basic Information
- Device Name
- CATHETERIZATION PROCED. TRAY, URETHRAL
- K Number
- K780124
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5130
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Walpak Co.
- Date Received
- January 24, 1978
- Decision Date
- February 21, 1978
- 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 Walpak Co.
| K Number | Device Name | ||
|---|---|---|---|
| K803200 | IRRIGATION SET W/BULB SYRINGE | Jan 21, 1981 | Substantially Equivalent |
| K803204 | IRRIGATION PISTON | Jan 21, 1981 | Substantially Equivalent |
| K803199 | SUTURE REMOVAL KIT | Jan 15, 1981 | Substantially Equivalent |
| K803198 | IRRIGATION SET W/PISTON SYRINGE | Jan 15, 1981 | Substantially Equivalent |
| K803201 | LEMON GLYCERINE SWABS | Dec 17, 1980 | Unknown |
| K802083 | CATHETER INSERTION TRAY | Sep 16, 1980 | Substantially Equivalent |
| K791598 | CLOSED SYSTEM FOLEY CATHERIZATION PROCED | Nov 16, 1979 | Substantially Equivalent |
| K780123 | CATHETERIZATION PROCEDURE TRAY | Feb 21, 1978 | Substantially Equivalent |
| K770446 | SPONGES, LAPAROTOMY | Jun 15, 1977 | Substantially Equivalent |
| K760560 | CATH CARE KIT | Nov 12, 1976 | Substantially Equivalent |