FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
URETHRAL CATHETERIZATION TRAY
K Number: K950390
·
Decision May 30, 1995
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
59
Applicant Total
11
Review Days
118
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
- URETHRAL CATHETERIZATION TRAY
- K Number
- K950390
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5130
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medcare Custom Packaging, Inc.
- Date Received
- February 1, 1995
- Decision Date
- May 30, 1995
- 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 Medcare Custom Packaging, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K954869 | MEDCARE YANKAUER SUCTION DEVICE | Jan 19, 1996 | Substantially Equivalent |
| K954442 | STERILE ISOTONIC SALINE & STERILE WATER | Dec 21, 1995 | Substantially Equivalent |
| K952759 | TOWEL PACK | Sep 29, 1995 | Substantially Equivalent |
| K943661 | STERILE PHYSIOLOGICAL SALINE/STERILE WATER | Apr 10, 1995 | Substantially Equivalent |
| K951149 | SINGLE USE INSTRUMENT TRAY | Apr 6, 1995 | Unknown |
| K934732 | PELVIC EXAM TRAY | Dec 30, 1994 | Substantially Equivalent |
| K942000 | BURN DRESSING TRAY | May 20, 1994 | Unknown |
| K936261 | CATHETER INSERTION TRAY | Mar 10, 1994 | Unknown |
| K922179 | CATHETER INSERTION TRAY | Jul 2, 1993 | Unknown |
| K901856 | CUSTOM WOUND MANAGEMENT KITS AND TRAYS | Aug 1, 1990 | Unknown |