FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UNIVERSAL URETHRAL CATHETER
K Number: K946282
·
Decision Mar 31, 1995
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
6
Applicant Total
12
Review Days
94
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Basic Information
- Device Name
- UNIVERSAL URETHRAL CATHETER
- K Number
- K946282
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5130
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Louisville Laboratories, Inc.
- Date Received
- December 27, 1994
- Decision Date
- March 31, 1995
- Product Code
- EZC
- 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 |
|---|---|---|---|
| EZC | Catheter, Coude | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Louisville Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K980123 | CARTER-THOMASON NEEDLE-POINT SUTURE PASSER INSTRUMENT SET | Mar 9, 1998 | Substantially Equivalent |
| K971796 | LAPAROTOMY BLADDER NECK SUSPENSION KIT WITH BONE ANCHORS | Aug 12, 1997 | Substantially Equivalent |
| K971791 | VAGINAL SUTURING KIT FOR LAPAROTOMY BLADDER NECK SUSPENSION | Jul 30, 1997 | Substantially Equivalent |
| K971802 | VAGINAL SUTURING KIT FOR BLADDER NECK SUSPENSION | Jul 30, 1997 | Substantially Equivalent |
| K971797 | LAPAROSCOPIC BLADDER NECK SUSPENSION KIT | Jul 22, 1997 | Substantially Equivalent |
| K971801 | LAPAROTOMY BLADDER NECK SUSPENSION KIT | Jul 22, 1997 | Substantially Equivalent |
| K963076 | LAPAROSCOPIC BONE ANCHORED URETHROPEXY INSTRUMENT TRAY | Apr 4, 1997 | Substantially Equivalent |
| K960882 | CONTROL SYRINGE | Jul 8, 1996 | Substantially Equivalent |
| K955535 | LOUISVILLE LABS OXYGEN HEAD TENT | Jul 1, 1996 | Substantially Equivalent |
| K932979 | EXTERNAL STABILITY PAD | Nov 2, 1993 | Substantially Equivalent |