URODYNAMICS TUBING KITS #5161, #5150, #7170
FDA 510(k) clearance K923995 · decided 1993-04-08
Clearance details
- K-number
- K923995
- Device name
- URODYNAMICS TUBING KITS #5161, #5150, #7170
- Applicant
- Advanced Medical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-08-10
- Decision date
- 1993-04-08
- Days to decision
- 241 days
- Clearance type
- Traditional
- Product code
- FAP
- Device class
- 2
- Regulation number
- 876.1620
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Merrillville, IN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SIGNAL GEAR URETHRAL CATHETER ELECTRODE (K113771) | Neurovision Medical Products, Inc. | 2012-12-13 |
| SINGLE CHANNEL UROLOGICAL PRESSURE GAUGE, DUAL CHANNEL UROLOGICAL PRESSURE GAUGE (K974775) | Airtronic Services, Inc. | 1998-02-19 |
| URODYNAMIC ANALYSIS MODULE (K963330) | Synectics Medical, Inc. | 1997-04-03 |
| RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETER (K962472) | Rusch Intl. | 1996-08-27 |
| SCHUSTER DISPOSABLE BALLOON PROBE (K931175) | Sandhill Scientific, Inc. | 1994-04-01 |
| UROLAB SPECTRUM (K931179) | Life-Tech Intl., Inc. | 1993-11-18 |
| URO-PRO 2000 (K922476) | Fiberoptic Sensor Technlogies, Inc. | 1993-07-20 |
| SYNECTICS LIBERTY SYSTEM, PC POLYGRAF/POLYGRAM URO (K924383) | Synectics-Dantec | 1993-06-18 |
| URODYNAMIC CATHETERS (K923464) | R.L. Medical Corp. | 1993-02-05 |
| NICKI, MODEL NUMBER USD-NK-UP1 (K924086) | Laborie Medical Technologies, Ltd. | 1992-10-20 |
| ENDOTEK ULTRA SYSTEM (K920451) | Surgitek | 1992-09-17 |
| LABORIE URODYNAMICS PROCESSOR (K920777) | R. Laborie Surgical , Ltd. | 1992-09-04 |
Recalls involving this device
No recalls on record reference this clearance.