FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CATH-CARE TRAY
K Number: K771652
·
Decision Sep 20, 1977
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
59
Applicant Total
14
Review Days
22
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- CATH-CARE TRAY
- K Number
- K771652
- 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
- August 29, 1977
- Decision Date
- September 20, 1977
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FCM), ordered by most recent decision date.
BD Touchless Plus Unisex Pre-Lubricated Urethral Catheter Kit
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter Insertion Kit (K2-90); Cure Catheter Insertion Kit (K3); Cure Hydrophilic Catheter Kit (HM12UK); Cure Hydrophilic Catheter Kit (HM14UK); Cure Hydrophilic Catheter Kit (HM16UK); Cure Pocket Catheter Kit (M14UK); Cure Catheter Closed System Kit (CS8); Cure Catheter Closed System Kit (CS10); Cure Catheter Closed System Kit (CS12); Cure Catheter Closed System Kit (CS14); Cure Catheter Closed System Kit (CS14C
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Self-Cath Closed System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
AMSELF CLOSED CATHETERIZATION SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GUARDIAN CATHETER-INFANT URINARY COLLECTION KIT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
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 |
| K780268 | BLADDER CATH KIT W/OUT CATHETER | Feb 24, 1978 | Substantially Equivalent |