Company ยท US
The Prometheus Group
FDA 510(k) clearances and medical device recalls filed under this name, 1991 to 2016. Name variants (Inc, Corp, punctuation) are merged.
11510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 15, 2016 | K160792 | Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder Ultrasound The Prometheus Group | IYO |
| May 23, 2003 | K030039 | PATHWAY STM-10 PELVIC FLOOR STIMULATOR The Prometheus Group | KPI |
| Feb 19, 2003 | K023906 | PATHWAY CTS2000 PELVIC FLOOR TRAINING SYSTEM The Prometheus Group | KPI |
| Jul 31, 2000 | K001515 | PATHWAY CTS 2000 PELVIC FLOOR TRAINING SYSTEM, MODEL PATHWAY CTS 2000 The Prometheus Group | KPI |
| Feb 22, 2000 | K993976 | PATHWAY VAGINAL EMG/STIM PERINEOMETER SENSOR, PATHWAY ANAL EMG/STIM PERINEOMETER SENSOR The Prometheus Group | KPI |
| Dec 22, 1997 | K974036 | PATHWAY VAGINAL/RECTAL PERINEOMETER PROBE The Prometheus Group | HIR |
| Dec 17, 1997 | K973537 | PATHWAY ELECTROMYOGRAPH The Prometheus Group | HCC |
| Jan 16, 1997 | K960508 | PATHWAY ELECTROMYOGRAPH MODEL PATHWAY II/MR-10/MR-15/MR-20/MR-25 The Prometheus Group | HIR |
| Aug 7, 1996 | K960761 | PATHWAY ELECTROMYOGRAPH MODEL TR-10 & TR-20 The Prometheus Group | HCC |
| Jun 13, 1996 | K960762 | SYNERGY PLUS The Prometheus Group | HCC |
| Apr 18, 1991 | K897132 | PATHWAY II ELECTROMYOGRAPH The Prometheus Group | HCC |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||