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Follicle Aspiration Set, Reduced Single Lumen

FDA 510(k)FDA UDI

Class II (US FDA 510(k))

510(k) K082727

by Vitrolife Sweden AB

Identity

Trade Name
Follicle Aspiration Set, Reduced Single Lumen FDA UDI
Generic Name
IVF oocyte aspiration needle, single-use FDA UDI
Model / Reference
14175 FDA UDI

Identifiers

Primary DI / UDI-DI
07350025914237 FDA UDI
510(k) Number
K082727 FDA 510(k)FDA UDI
FDA Product Code
MQE FDA 510(k)FDA UDI
GMDN Term
IVF oocyte aspiration needle, single-use FDA UDI

Classification

Device Class
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 884.6100 FDA 510(k)
Regulation Number
884.6100 FDA 510(k)FDA UDI
Advisory Committee
Obstetrics/Gynecology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

The Follicle Aspiration Set, Reduced Single Lumen is a Needle, Assisted Reproduction device designed for the retrieval of oocytes from ovarian follicles. It is classified under the Obstetrics/Gynecology specialty and falls under Device Class II, indicating moderate risk. The set is engineered to facilitate precise aspiration and flushing of follicles during assisted reproductive procedures, ensuring efficient oocyte retrieval while minimizing patient discomfort.

This single-use device is supplied sterile and intended for use in clinical settings where assisted reproduction techniques are performed. It includes a reduced single lumen needle with a Luer connection, compatible with standard syringes for media flushing and aspiration. The set adheres to FDA 510(k) clearance under the Traditional pathway, with a K-number (K082727) and product code (MQE). Storage and handling must follow sterile medical device protocols to maintain integrity before use.

Frequently asked questions

What is the Follicle Aspiration Set, Reduced Single Lumen used for?

This device is specifically designed for the retrieval of oocytes (eggs) from ovarian follicles during assisted reproductive procedures, such as in vitro fertilization (IVF). Its reduced single lumen needle allows for precise aspiration and flushing of follicles, helping to streamline the process while reducing patient discomfort.

Is the Follicle Aspiration Set, Reduced Single Lumen single-use or reusable?

The Follicle Aspiration Set, Reduced Single Lumen is intended for single-use only. This ensures sterility and safety for each procedure, as reusing medical devices can introduce contamination risks and compromise patient care.

How is the Follicle Aspiration Set, Reduced Single Lumen supplied and what does it include?

The set is supplied sterile and ready for immediate clinical use. It includes a reduced single lumen needle with a Luer connection, which is compatible with standard syringes for media flushing and aspiration. This design simplifies handling and ensures compatibility with existing workflows in assisted reproduction clinics.

What storage and handling precautions should be taken with this device?

Since the Follicle Aspiration Set is sterile and single-use, it must be stored in accordance with sterile medical device protocols to maintain its integrity before use. This includes keeping it in a sealed, uncontaminated environment, away from direct sunlight or extreme temperatures, and ensuring the packaging remains intact until use.

What regulatory pathway does this device follow?

The Follicle Aspiration Set, Reduced Single Lumen follows the FDA’s Traditional 510(k) clearance pathway, with a K-number (K082727) and product code (MQE). This pathway confirms that the device is substantially equivalent to a legally marketed predicate device, ensuring it meets regulatory standards for safety and effectiveness in assisted reproduction procedures.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF Foll Asp Set_26019-10 dr5 - Vitrolife, Follicle Aspiration Set, Reduced Single Lumen (K172050) — FDA 510(k ..., Follicle Aspiration Set Reduced Single Lumen, Conventional Single and Double Lumen - Vitrolife, Vitrolife Sweden AB 17177 Follicle Aspiration Set Reduced Single Lumen

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Vitrolife Sweden AB

Sources (2)

  • FDA 510(k) K082727 24 fields · synced Oct 1, 2026
  • FDA UDI 23ddc15b-99e1-4c5f-9fbe-f2cae77ffc51 34 fields · synced May 26, 2026