Minitub Multi-Purpose Cassettes

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K002961 ↗

FDA Product Code

MQG

Device Class

Class II

Regulation

21 CFR Part 884.6120

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• DB1 Embryo Freeze

  Class II

  FDA 510(k) K011327 Active Cleared 15 Aug 2002

• Rs Biotech Galaxy 'r' CO2 Incubator

  Class II

  FDA 510(k) K003184 Active Cleared 20 Nov 2000

• Zivf-Aire

  Class II

  FDA 510(k) K041952 Active Cleared 8 Sep 2005

• Mtg - Minitub Heated Stage Systems

  Class II

  FDA 510(k) K002971 Active Cleared 15 Dec 2000

• What clinical procedures are these cassettes designed to support in assisted reproduction settings?

  The Minitub Multi-Purpose Cassettes are specifically designed to assist with aspirating, incubating, infusing, and maintaining temperature for reproductive cells or embryos during handling and processing. This makes them useful in fertility clinics and ART laboratories for tasks like embryo culture, sperm preparation, or oocyte handling where controlled conditions are critical.

• Are these cassettes intended for single-use or can they be reused after sterilization?

  These cassettes are explicitly labeled as single-use items, though they must be sterilized prior to application. While they can be sterilized, the manufacturer does not recommend or endorse reuse beyond the intended single-use cycle, as sterilization may compromise their integrity or functionality over time.

• What storage conditions should be followed for these cassettes before use?

  The cassettes should be stored according to standard sterile medical device protocols. Since they are non-sterile before use, they must undergo sterilization prior to application in clinical settings. Ensure they are kept in a clean, dry environment away from direct sunlight or extreme temperatures until ready for sterilization.

• What sizes or models of these cassettes are available, and how do they differ?

  The data provided lists multiple registration numbers (e.g., 3008157119, 1825146, etc.), which likely correspond to different sizes or variations of the Minitub Multi-Purpose Cassettes. While exact dimensions or model-specific features aren’t detailed, these variations may cater to different procedural needs, such as varying volumes or incubation capacities. Contact Zander Medical Supplies for specific sizing or model comparisons.

• How was the regulatory pathway for this device determined, and what does that mean for clinicians?

  The Minitub Multi-Purpose Cassettes were cleared through the FDA’s 510(k) process, specifically under the Traditional route, and classified as a Class II device. This means the manufacturer demonstrated that the device is substantially equivalent to a legally marketed predicate device (already on the market) in terms of technology and safety. Clinicians can rely on this pathway as evidence that the device meets FDA standards for assisted reproduction accessories, though they should always follow the manufacturer’s instructions for use.