FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PROINSERT
K Number: K131145
·
Decision Feb 20, 2014
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
49
Applicant Total
12
Review Days
303
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Basic Information
- Device Name
- PROINSERT
- K Number
- K131145
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.6160
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nidacon International AB
- Date Received
- April 23, 2013
- Decision Date
- February 20, 2014
- Product Code
- MQK
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MQK | Labware, Assisted Reproduction | FDA class 2 | Obstetrics/Gynecology |
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Other Clearances by Nidacon International AB
| K Number | Device Name | ||
|---|---|---|---|
| K092107 | VITRIBLAST, THERMOBLAST, MODEL VB-010, TB-010 | Jun 15, 2010 | Substantially Equivalent |
| K023206 | SPERM CRYOPROTEC | Nov 8, 2002 | Substantially Equivalent |
| K022443 | SPERMASSIST | Aug 28, 2002 | Substantially Equivalent |
| K011607 | SPERMCATCH | Aug 10, 2001 | Substantially Equivalent |
| K012123 | NIDOIL | Aug 3, 2001 | Substantially Equivalent |
| K011606 | PURESPERM BUFFER | Jul 12, 2001 | Substantially Equivalent |
| K011346 | READYSWIM | Jun 28, 2001 | Substantially Equivalent |
| K002630 | PURESPERM WASH | Nov 21, 2000 | Substantially Equivalent |
| K002623 | PURESPERM 40 AND PURESPERM 80 | Nov 20, 2000 | Substantially Equivalent |
| K984172 | MODIFICATION OF PURESPERM | Jan 14, 1999 | Substantially Equivalent |