Pathway Vaginal/Rectal Perineometer Probe
FDA 510(k) K974036 · The Prometheus Group
510(k) numberK974036
Submission
- Device name
- Pathway Vaginal/Rectal Perineometer Probe
- Applicant
- The Prometheus Group
Duxbury, MA, US - Received
- October 24, 1997
- Decision date
- December 22, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HIR – Perineometer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.1425
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HIR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252748 | Pelvic Floor Exerciser (PF01)HIR · Traditional | Hunan Accurate Bio-Medical Technology Co., Ltd. | 04/27/2026SE |
| K240805 | Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5)HIR · Traditional | Pelvital USA, Inc. | 08/01/2024SE |
| K231875 | Vaginal Tactile Ultrasound ImagerHIR · Traditional | Advanced Tactile Imaging, Inc. | 02/22/2024SE |
| K233362 | Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0)HIR · Special | Pelvital USA, Inc. | 12/29/2023SE |
| K231780 | Perifit Care+HIR · Traditional | X6 Innovations | 12/20/2023SE |
| K221476 | PerifitHIR · Traditional | X6 Innovations | 02/10/2023SE |
| K213913 | leva Pelvic Health SystemHIR · Traditional | Renovia, Inc. | 06/30/2022SE |
| K212655 | FlyteHIR · Special | Pelvital USA, Inc. | 09/21/2021SE |
| K212495 | Leva Pelvic Health SystemHIR · Special | Renovia, Inc. | 09/08/2021SE |
| K210764 | FlyteHIR · Special | Pelvital USA, Inc. | 04/13/2021SE |
More from Pelvital USA, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K160792 | Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder UltrasoundIYO · Traditional | 04/15/2016SE |
| K030039 | Pathway STM-10 Pelvic Floor StimulatorKPI · Traditional | 05/23/2003SE |
| K023906 | Pathway CTS2000 Pelvic Floor Training SystemKPI · Traditional | 02/19/2003SE |
| K001515 | Pathway CTS 2000 Pelvic Floor Training System, Model Pathway CTS 2000KPI · Traditional | 07/31/2000SE |
| K993976 | Pathway Vaginal Emg/Stim Perineometer Sensor, Pathway Anal Emg/Stim Perineometer SensorKPI · Traditional | 02/22/2000SE |
| K973537 | Pathway ElectromyographHCC · Traditional | 12/17/1997SE |
| K960508 | Pathway Electromyograph Model Pathway II/MR-10/MR-15/MR-20/MR-25HIR · Traditional | 01/16/1997SE |
| K960761 | Pathway Electromyograph Model TR-10 & TR-20HCC · Traditional | 08/07/1996SE |
| K960762 | Synergy PlusHCC · Traditional | 06/13/1996SE |
| K897132 | Pathway II ElectromyographHCC · Traditional | 04/18/1991SE |
Questions and answers
When was Pathway Vaginal/Rectal Perineometer Probe cleared by the FDA?
Pathway Vaginal/Rectal Perineometer Probe (K974036) received a 510(k) decision of Substantially Equivalent on December 22, 1997, 59 days after the submission was received.
What is the product code of K974036?
The FDA product code is HIR – Perineometer, a Class II (moderate risk) device regulated under 21 CFR 884.1425.