Medical Device Manufacturer · US , Portsmouth , NH

The Prometheus Group - FDA 510(k) Cleared Devices

11 submissions · 11 cleared · Since 1991

11

Total

11

Cleared

0

Denied

FDA 510(k) Regulatory Record - The Prometheus Group Gastroenterology & Urology ✕

6 devices

1-6 of 6

Cleared May 23, 2003

PATHWAY STM-10 PELVIC FLOOR STIMULATOR

Gastroenterology & Urology · 137d

Cleared Feb 19, 2003

PATHWAY CTS2000 PELVIC FLOOR TRAINING SYSTEM

Gastroenterology & Urology · 89d

Cleared Jul 31, 2000

PATHWAY CTS 2000 PELVIC FLOOR TRAINING SYSTEM, MODEL PATHWAY CTS 2000

Gastroenterology & Urology · 76d

Cleared Feb 22, 2000

PATHWAY VAGINAL EMG/STIM PERINEOMETER SENSOR, PATHWAY ANAL EMG/STIM...

Gastroenterology & Urology · 90d

Cleared Dec 22, 1997

PATHWAY VAGINAL/RECTAL PERINEOMETER PROBE

Gastroenterology & Urology · 59d

Cleared Jan 16, 1997

PATHWAY ELECTROMYOGRAPH MODEL PATHWAY II/MR-10/MR-15/MR-20/MR-25

Gastroenterology & Urology · 346d