Panels › Gastroenterology, Urology › Product code FAP · Class 2
Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
Regulation 876.1620
0510(k)s in 12 months (85 all time)
0recalls in 12 months (6 all time)
5recalls that name a 510(k)
Top companies in FAP
| Company | 510(k)s | Recalls |
|---|---|---|
| Life-Tech Intl., Inc. | 14 | 0 |
| Browne Corp. | 7 | 0 |
| Browne Medical Systems, Inc. | 7 | 0 |
| Dantec Medical, Inc. | 6 | 0 |
| Sandhill Scientific, Inc. | 1 | 3 |
| Warne Surgical Products, Ltd. | 4 | 0 |
| Dantec Electronics, Inc. | 3 | 0 |
| Diagnostic Ultrasound Corp. | 3 | 0 |
| Biosearch Medical Products, Inc. | 2 | 0 |
| Browne Medical, Inc. | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 8, 2021 | Spes Medica SNS Disposable Urethral Catheter Electrode, 14 Fr, Gold Recording/Stimulating Contact printed on polyurethane film adhesive with attached 2 meter lead-wire with touch-proof connector, Reference Number Terminated |
FAP | K113771 |
| Apr 8, 2021 | Spes Medica SNS Disposable Urethral Catheter Electrode, 10 Fr, Gold Recording/Stimulating Contact printed on polyurethane film adhesive with attached 2 meter lead-wire with touch-proof connector, Reference Number Terminated |
FAP | K113771 |
| Apr 12, 2018 | Teleflex Medical Europe Ltd Rectal Catheters;
Product Code Equivalent Code
580114 580114
Product Usage:
Rectal Balloon Catheter is inserted into the rectum to measure the abdominal pressure as bladder filled. Terminated |
FAP | K962472 |
| Jan 6, 2006 | Sandhill Scientific, Inc Schuster Anorectal Manometry Probe. Labeling applied to the ballon pouch reads in part: ''SANDHILL SCIENTIFIC SCHUSTER ANORECTAL MANOMETRY PROBE Rectosphincteric Manometry Balloon Probe Manufactured Terminated |
FAP | None listed |
| Jan 6, 2006 | Sandhill Scientific, Inc Replacement balloons for use with Sandhill Anorectal Manometry Probes. There is no labeling other than the part number for these products. Terminated |
FAP | K931175 |
| Jan 6, 2006 | Sandhill Scientific, Inc Schuster Anorectal Manometry Probe. Labeling applied to the ballon pouch reads in part: ''SANDHILL SCIENTIFIC SCHUSTER ANORECTAL MANOMETRY PROBE Rectosphincteric Manometry Balloon Probe Manufactured Terminated |
FAP | K931175 |
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