Proinsert
FDA 510(k) K131145 · Nidacon International AB
510(k) numberK131145
Submission
- Device name
- Proinsert
- Applicant
- Nidacon International AB
Naples, FL, US - Received
- April 23, 2013
- Decision date
- February 20, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MQK – Labware, Assisted Reproduction
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.6160
- Specialty
- Obstetrics/Gynecology
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More from Allwin Medical Devices, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K092107 | Vitriblast, Thermoblast, Model VB-010, TB-010MQL · Traditional | 06/15/2010SE |
| K023206 | Sperm CryoprotecMQL · Traditional | 11/08/2002SE |
| K022443 | SpermassistMQL · Traditional | 08/28/2002SE |
| K011607 | SpermcatchMQL · Traditional | 08/10/2001SE |
| K012123 | NidoilMQL · Traditional | 08/03/2001SE |
| K011606 | Puresperm BufferMQL · Traditional | 07/12/2001SE |
| K011346 | ReadyswimMQL · Traditional | 06/28/2001SE |
| K002630 | Puresperm WashMQL · Traditional | 11/21/2000SE |
| K002623 | Puresperm 40 and Puresperm 80MQL · Traditional | 11/20/2000SE |
| K984172 | Modification of PurespermMQL · Traditional | 01/14/1999SE |
Questions and answers
When was Proinsert cleared by the FDA?
Proinsert (K131145) received a 510(k) decision of Substantially Equivalent on February 20, 2014, 303 days after the submission was received.
What is the product code of K131145?
The FDA product code is MQK – Labware, Assisted Reproduction, a Class II (moderate risk) device regulated under 21 CFR 884.6160.