FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UROLOGICAL CATHETER & ACCESSORIES
K Number: K841727
·
Decision Jun 7, 1984
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
237
Applicant Total
35
Review Days
43
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
- UROLOGICAL CATHETER & ACCESSORIES
- K Number
- K841727
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5130
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Research Medical, Inc.
- Date Received
- April 25, 1984
- Decision Date
- June 7, 1984
- Product Code
- KOD
- 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 |
|---|---|---|---|
| KOD | Catheter, Urological | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KOD), ordered by most recent decision date.
Rubber Utility Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Wellead Ureteral Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
allFlex Ureteral Catheters, Krait Ureteral Catheters
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Urinary Catheter 12 Fr, Urinary Catheter 16 Fr
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
UroGen Ureteral Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Research Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K970739 | RMI HEMOCONCENTRATOR PREFERENCE PACK | Jul 8, 1997 | Substantially Equivalent |
| K964833 | RMI DUAL FLUID IRRIGATING SYRINGE | Feb 19, 1997 | Substantially Equivalent |
| K961927 | RMI HEMOCONCENTRACTOR TUBING SET | Aug 13, 1996 | Substantially Equivalent |
| K960098 | RMI INTERNAL MAMMARY ARTERY CANNULA | Mar 26, 1996 | Substantially Equivalent |
| K951344 | RMI HEMOCONCENTRATOR | Aug 15, 1995 | Substantially Equivalent |
| K922083 | RMI SURGICCAL SITE VISUALIZATION WAND | Jan 29, 1993 | Substantially Equivalent |
| K920936 | RMI EXTERNAL CORONARY ARTERY OCCLUDER | Dec 18, 1992 | Substantially Equivalent |
| K915869 | RMI NORMOCLUDER CORONARY ARTERY OCCLUDER | Dec 8, 1992 | Substantially Equivalent |
| K920676 | RMI SOFCLAMP | Apr 15, 1992 | Substantially Equivalent |
| K910221 | RMI VASCULAR TOURNIQUET KIT | May 16, 1991 | Substantially Equivalent |