FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACKRAD V/CUG VOIDING CYSTOURETHROGRAPHY SET
K Number: K874293
·
Decision Dec 29, 1987
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
237
Applicant Total
42
Review Days
70
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
- ACKRAD V/CUG VOIDING CYSTOURETHROGRAPHY SET
- K Number
- K874293
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5130
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Ackrad Laboratories
- Date Received
- October 20, 1987
- Decision Date
- December 29, 1987
- 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 Ackrad Laboratories
| K Number | Device Name | ||
|---|---|---|---|
| K021272 | SIB CATHETER, MODEL 61-7005 | May 21, 2002 | Substantially Equivalent |
| K020954 | H/S PROCEDURE TRAY (5F), H/S PROCEDURE TRAY (7F), H/S ELLIPTOSPHERE PROCEDURE TRAY & MULTIPURPOSE PROCEDURE TRAY | Apr 24, 2002 | Substantially Equivalent |
| K020951 | H/S CATHETER SET (5F), MODEL 61-5005; H/S CATHETER SET (7F), MODEL 61-5007 | Apr 16, 2002 | Substantially Equivalent |
| K970492 | INTRAUTERINE INSEMINATION AND SONOHYSTEROGRAPHY CATHETER | Apr 9, 1997 | Substantially Equivalent |
| K961752 | H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607) | Aug 8, 1996 | Substantially Equivalent |
| K940176 | ACKRAD IUI SET FOR INTRAUTERINE INSEMINATION | Apr 23, 1996 | Substantially Equivalent |
| K952542 | ACKRAD ESOPHAGEAL BALLOON CATHETER SET | Apr 23, 1996 | Substantially Equivalent |
| K953034 | H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607) | Aug 29, 1995 | Substantially Equivalent |
| K915813 | ACKRAD ERCP CONTRAST DELIVERY SET | Mar 11, 1992 | Substantially Equivalent |
| K904499 | NICOS (NON-INVASIVE CARDIAC OUTPUT SYSTEM) | Jul 1, 1991 | Substantially Equivalent |