Spermcatch
510(k) K011607
Spermcatch is a medical device (FDA Class II; FDA product code MQL, Media, Reproductive) made by Nidacon International Ab, cleared under FDA 510(k) K011607 on 10 Aug 2001, active as of 10 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK011607 | Date10 Aug 2001 | StatusActive |
Official records
- FDA 510(k) database K011607
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MQL
- Device class
- Class II
- Regulation
- 21 CFR Part 884.6180
- Advisory committee
- Obstetrics/Gynecology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K011607
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Nidacon SpermCatch | SC-100 / SpermCatch | 07350025610146 | — | On the market |
Similar devices
Other devices filed under FDA product code MQL (Media, Reproductive).
- PVP 7% ART-4005-A by CooperSurgical, Inc.
- Quinn's Advantage Fertilization (HTF) ART-1020 by CooperSurgical, Inc.
- MEDI-CULT M3 MEDIUM by Medicult A/S
- Synvitro Hyadase by Origio A/S, A Coopersurgical Company
- G-THAWKIT BLAST by Vitrolife AB
- Gx-MOPS PLUS 10173 by Vitrolife Sweden AB
- Vitavitro Vitrification Kit, Vitavitro Warming Kit, and Vitavitro Straw Set by Shenzhen Vitavitro Bio-Tech Co., Ltd.
- Gx-IVF 10171 by Vitrolife Sweden AB
- Sydney IVF Blastocyst Cryopreservation Kit, Sydney IVF Blastocyst Thawing Kit by WILLIAM A. COOK AUSTRALIA PTY. LTD.
- SYDNEY IVF CULTURE OIL by Cook Urological, Inc.