SWEMED INTRACYTOPLASMIC SPERM INJECTION - Holding Pipttes
by Swemed Lab International AB
510(k) K991700
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK991700 | Date19 Jul 1999 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- MQH
- Models / Variants
- Holding Pipttes
- Device Class
- Class II
- Regulation
- 21 CFR Part 884.6130
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
These pipettes are classified as microtools for assisted reproduction, designed specifically for intracytoplasmic sperm injection (ICSI) procedures. The set includes micro-injection pipettes for sperm insertion, holding pipettes to stabilize oocytes, denuding pipettes to remove surrounding cells, and assisted zona drilling pipettes for embryo manipulation.
Used in clinical laboratory settings by embryologists or trained technicians, these pipettes are intended for single-use applications in assisted reproductive technology. The device carries an FDA 510(k) clearance under classification MQH, with a decision of Substantially Equivalent (SESE) and regulatory coverage under 884.6130. Multiple registration numbers and FEI numbers are associated with the product code, reflecting its compliance and distribution for obstetrics/gynecology applications.