Silastic Brand Intravaginal Tarsette
FDA 510(k) K771548 · Dow Corning Corp. Healthcare Industries Materials
510(k) numberK771548
Submission
- Device name
- Silastic Brand Intravaginal Tarsette
- Applicant
- Dow Corning Corp. Healthcare Industries Materials
Mchenry, IL, US - Received
- August 12, 1977
- Decision date
- November 7, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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| 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 |
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| K173351 | Panpac Flexi Shelf PessaryHHW · Abbreviated | Panpac Medical Corporation | 10/31/2018SE |
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| K831479 | Metal-Backed Acetabular CupDXQ · Traditional | 06/15/1983SE |
| K812864 | Silastic Voice ProsthesisEWL · Traditional | 11/24/1981SE |
| K812053 | Silastic Hemi Wrist Implant H.P. (Rad.)KXE · Traditional | 08/18/1981SE |
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Questions and answers
When was Silastic Brand Intravaginal Tarsette cleared by the FDA?
Silastic Brand Intravaginal Tarsette (K771548) received a 510(k) decision of Substantially Equivalent on November 7, 1977, 87 days after the submission was received.
What is the product code of K771548?
The FDA product code is HHW – Pessary, Vaginal, a Class II (moderate risk) device regulated under 21 CFR 884.3575.