PATHWAY CTS 2000 PELVIC FLOOR TRAINING SYSTEM, MODEL PATHWAY CTS 2000
FDA 510(k) clearance K001515 · decided 2000-07-31
Clearance details
- K-number
- K001515
- Device name
- PATHWAY CTS 2000 PELVIC FLOOR TRAINING SYSTEM, MODEL PATHWAY CTS 2000
- Applicant
- The Prometheus Group
- Decision
- Substantially Equivalent
- Date received
- 2000-05-16
- Decision date
- 2000-07-31
- Days to decision
- 76 days
- Clearance type
- Traditional
- Product code
- KPI
- Device class
- 2
- Regulation number
- 876.5320
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Duxbury, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.