FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BLADDER CATH KIT W/OUT CATHETER
K Number: K780268
·
Decision Feb 24, 1978
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
59
Applicant Total
14
Review Days
7
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Basic Information
- Device Name
- BLADDER CATH KIT W/OUT CATHETER
- K Number
- K780268
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5130
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Latex Ind., Inc.
- Date Received
- February 17, 1978
- Decision Date
- February 24, 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 Latex Ind., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K812058 | AKRON URINARY DRAINAGE BAT | Jul 31, 1981 | Substantially Equivalent |
| K810281 | UROLOGICAL CATHETERS | Feb 25, 1981 | Substantially Equivalent |
| K791674 | BLADDER RETENTION CATHETERIZATION TRAY | Nov 5, 1979 | Substantially Equivalent |
| K781751 | CATHETER, AKRON FOLEY TEFLON | Jan 22, 1979 | Substantially Equivalent |
| K781433 | AKRON MALE EXTERNAL CATHETER | Nov 3, 1978 | Substantially Equivalent |
| K772277 | BLADDER RETENTION-CATHETHERIZATIONTRAY | Mar 2, 1978 | Substantially Equivalent |
| K780267 | CATH TRAY W/OUT CATHETER | Feb 24, 1978 | Substantially Equivalent |
| K772342 | ROBINSON KIT - 750014 & 750016 | Feb 24, 1978 | Substantially Equivalent |
| K772340 | CATHETERIZATION KIT 732016-732018 | Feb 24, 1978 | Substantially Equivalent |
| K772341 | BLADDER KIT - 734000 | Feb 24, 1978 | Substantially Equivalent |