Pelvx Gellhorn Vaginal Pessary 603-608
FDA 510(k) K002329 · Deschutes Medical Products, Inc.
510(k) numberK002329
Submission
- Device name
- Pelvx Gellhorn Vaginal Pessary 603-608
- Applicant
- Deschutes Medical Products, Inc.
Bend, OR, US - Received
- August 1, 2000
- Decision date
- September 18, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HHW – Pessary, Vaginal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.3575
- Specialty
- Obstetrics/Gynecology
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253698 | Milex Incontinence Dish Pessaries; Milex Incontinence Dish Pessaries with Support…HHW · Traditional | Cooper Surgical | 01/20/2026SE |
| K250438 | CooperSurgical Milex® PessariesHHW · Traditional | CooperSurgical, Inc. | 04/11/2025SE |
| K240798 | Cntrl+ Bladder Support PessaryHHW · Traditional | Cntrl+, Inc. | 12/17/2024SE |
| K232677 | Reia pessaryHHW · Traditional | Reia, LLC | 05/21/2024SE |
| K232525 | Yoni.Fit Bladder SupportHHW · Traditional | Watkins-Conti Products, Inc. | 05/17/2024SE |
| K233548 | Uresta®HHW · Traditional | Resilia, Inc. | 04/03/2024SE |
| K231786 | Gynethotics PessaryHHW · Traditional | Cosm Medical | 03/06/2024SE |
| K190277 | ProVate Vaginal SupportHHW · Traditional | Contipi Medical , Ltd. | 07/08/2019SE |
| K183468 | Revive Reusable Bladder SupportHHW · Traditional | Rinovum Subsidiary 2, LLC | 01/25/2019SE |
| K173351 | Panpac Flexi Shelf PessaryHHW · Abbreviated | Panpac Medical Corporation | 10/31/2018SE |
More from Panpac Medical Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K994079 | Reflex Treatment SystemHIR · Traditional | 03/01/2000SE |
| K990593 | Pelvx Incontinence Dish, Model 301-306HHW · Traditional | 05/24/1999SE |
| K974117 | Pelvx Donut, Pelvx CubeHHW · Traditional | 04/27/1998SE |
| K974116 | Pelvx Incontinence RingHHW · Traditional | 04/27/1998SE |
| K974115 | Pelvx Ring, Pelvx Ring with SupportHHW · Traditional | 04/27/1998SE |
| K934552 | PeripumpHIR · Traditional | 08/09/1995SE |
| K951569 | SurgactivatorLJH · Traditional | 06/06/1995SE |
Questions and answers
When was Pelvx Gellhorn Vaginal Pessary 603-608 cleared by the FDA?
Pelvx Gellhorn Vaginal Pessary 603-608 (K002329) received a 510(k) decision of Substantially Equivalent on September 18, 2000, 48 days after the submission was received.
What is the product code of K002329?
The FDA product code is HHW – Pessary, Vaginal, a Class II (moderate risk) device regulated under 21 CFR 884.3575.