FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UNIVERSAL DRAINAGE TRAY
K Number: K961442
·
Decision May 9, 1996
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
59
Applicant Total
36
Review Days
24
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
- UNIVERSAL DRAINAGE TRAY
- K Number
- K961442
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5130
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Customed, Inc.
- Date Received
- April 15, 1996
- Decision Date
- May 9, 1996
- 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 Customed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K974647 | FANFOLD DRAPE 41 X 57 PRODUCT NO. 900-633, RECORDER NO. 0633 | Jan 5, 1998 | Substantially Equivalent |
| K971920 | GOWN POLY REINFORCED LARGE(PRODUCT NO.900-522)/(REORDER NO. 0522) | Dec 4, 1997 | Substantially Equivalent |
| K964011 | SUCTION CATHETER TRAY PRODUCT NO. 900277 | Nov 25, 1996 | Unknown |
| K962652 | URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749) | Oct 4, 1996 | Substantially Equivalent |
| K962596 | CUSTOMED BLOOD EXTRACTION KIT | Sep 27, 1996 | Substantially Equivalent |
| K953678 | STERIMED STERIZATION WRAPPER (NON-STERILE) | Oct 2, 1995 | Substantially Equivalent |
| K950295 | WOUND CLOSURE/LACERATION TRAY | Apr 18, 1995 | Substantially Equivalent |
| K942177 | FOLEY CATHETERIZATION TRAY | Sep 8, 1994 | Substantially Equivalent |
| K925018 | IV PREP KIT W/O DRESSING (NON-STERILE) | Aug 27, 1993 | Unknown |
| K925017 | IV PREP KIT (NON-STERILE) | Aug 27, 1993 | Substantially Equivalent |