Swemed Intracytoplasmic Sperm Injection (Icsi) Micro-Injection Pipettes; Holding Pipttes; Denuding Pipettes; Assisted/Zo
FDA 510(k) K991700 · Swemed Lab International AB
510(k) numberK991700
Submission
- Device name
- Swemed Intracytoplasmic Sperm Injection (Icsi) Micro-Injection Pipettes; Holding Pipttes; Denuding Pipettes; Assisted/Zo
- Applicant
- Swemed Lab International AB
Billdal, SE - Received
- May 18, 1999
- Decision date
- July 19, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MQH – Microtools, Assisted Reproduction (Pipettes)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.6130
- Specialty
- Obstetrics/Gynecology
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| K250838 | Denudation PipettesMQH · Traditional | Guangzhou Pinzhi Medical Device Co., Ltd. | 07/03/2025SE |
| K192146 | V-DenupetMQH · Traditional | Vitromed GmbH | 01/28/2020SE |
| K161275 | EZ-Tip Singles, EZ-Tip Vial of 20, EZ-GripMQH · Traditional | Research Instruments Limited | 01/23/2017SE |
| K152581 | LifeGlobal Micro TipsMQH · Traditional | Life Global Group, LLC | 04/11/2016SE |
| K151018 | Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction PipetteMQH · Traditional | Cook Incorporated | 01/08/2016SE |
| K150748 | Flexipet Denuding Pipette, Flexipet Manipulation PipetteMQH · Traditional | Cook Incorporated | 12/18/2015SE |
| K133257 | Biopsy PipettesMQH · Traditional | Research Instruments , Ltd. | 05/16/2014SE |
| K102480 | Injection Pipette; Holding Pipette; Biopsy Pipette; Denuding Pipette; Partial Zona…MQH · Traditional | Jieying Laboratory, Inc. | 04/19/2011SE |
| K092554 | Blastomere Biopsy Pipettes, Polar Body Biopsy PipettesMQH · Traditional | Sunlight Medical, Inc. | 04/30/2010SE |
| K072600 | Intracytoplasmic Sperm and Spermatid Injection, Holding, Zone Drilling, Partial Zone…MQH · Traditional | Sunlight Medical, Inc. | 05/19/2008SE |
More from Sunlight Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K053208 | Clear Vision Embryo Transfer Catheter Set, Model B100000 - B 100007; Clear Vision Trial…MQF · Abbreviated | 01/30/2006SE |
| K022643 | Blastomere Biopsy Pipette, Models H-55530 and H-55540MQH · Traditional | 11/05/2002SE |
| K991273 | Swemed Follicle Aspiration Set, Double Lumen, Single Lumen, and Luer NeedleMQE · Traditional | 08/18/1999SE |
Questions and answers
When was Swemed Intracytoplasmic Sperm Injection (Icsi) Micro-Injection Pipettes; Holding Pipttes; Denuding Pipettes; Assisted/Zo cleared by the FDA?
Swemed Intracytoplasmic Sperm Injection (Icsi) Micro-Injection Pipettes; Holding Pipttes; Denuding Pipettes; Assisted/Zo (K991700) received a 510(k) decision of Substantially Equivalent on July 19, 1999, 62 days after the submission was received.
What is the product code of K991700?
The FDA product code is MQH – Microtools, Assisted Reproduction (Pipettes), a Class II (moderate risk) device regulated under 21 CFR 884.6130.