FAP — Cystometric Gas (Carbon-Dioxide) On Hydraulic Device Class II
FDA product code FAP covers "Cystometric Gas (Carbon-Dioxide) On Hydraulic Device", a Class II medical device regulated under 21 CFR 876.1620. Submissions are reviewed by the Gastroenterology, Urology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FAP
- Device Class
- Class II
- Regulation Number
- 876.1620
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K113771 | neurovision medical products | SIGNAL GEAR URETHRAL CATHETER ELECTRODE | December 13, 2012 |
| K974775 | airtronic services | SINGLE CHANNEL UROLOGICAL PRESSURE GAUGE, DUAL CHANNEL UROLOGICAL PRESSURE GAUGE | February 19, 1998 |
| K963330 | synectics medical | URODYNAMIC ANALYSIS MODULE | April 3, 1997 |
| K962472 | rusch intl | RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETER | August 27, 1996 |
| K931175 | sandhill scientific | SCHUSTER DISPOSABLE BALLOON PROBE | April 1, 1994 |
| K931179 | life-tech intl | UROLAB SPECTRUM | November 18, 1993 |
| K922476 | fiberoptic sensor technlogies | URO-PRO 2000 | July 20, 1993 |
| K924383 | synectics-dantec | SYNECTICS LIBERTY SYSTEM, PC POLYGRAF/POLYGRAM URO | June 18, 1993 |
| K923995 | advanced medical products | URODYNAMICS TUBING KITS #5161, #5150, #7170 | April 8, 1993 |
| K923464 | r.l. medical | URODYNAMIC CATHETERS | February 5, 1993 |
| K924086 | laborie medical technologies | NICKI, MODEL NUMBER USD-NK-UP1 | October 20, 1992 |
| K920451 | surgitek | ENDOTEK ULTRA SYSTEM | September 17, 1992 |
| K920777 | r. laborie surgical | LABORIE URODYNAMICS PROCESSOR | September 4, 1992 |
| K920575 | f.m. wiest usa | MERKUR 4000 | July 23, 1992 |
| K914300 | aspen medical | PHOENIX 5 URODYNAMICS SYSTEM | June 2, 1992 |
| K921047 | browne medical systems | MODEL 8100 URODYNAMICS MEASURING SYSTEM | April 10, 1992 |
| K920991 | browne medical systems | IMAGE PRO URODYNAMICS MEASURING SYST, MODIFICATION | April 10, 1992 |
| K920992 | browne medical systems | PROFILE PLUS URODYNAMICS MEASURING SYST, MODIFIED | April 10, 1992 |
| K915484 | life-tech intl | URETHRALPRESSURE PROFILE CATHETER | February 24, 1992 |
| K915443 | cook urological | URODYNAMIC CATHETER | February 19, 1992 |