PBS(-) Phosphate Buffered Saline

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K160863 ↗

FDA Product Code

MQL

FDA applicant

Kitazato Biopharma Co., Ltd.

Device Class

Class II

Regulation

21 CFR Part 884.6180

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

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• What specific clinical applications is this PBS(-) Phosphate Buffered Saline designed for within reproductive procedures?

  This PBS(-) Phosphate Buffered Saline is specifically designed for cell washing, particularly for oocytes during assisted reproductive procedures. Its calcium- and magnesium-free formulation makes it suitable for maintaining physiological conditions without interfering with cell integrity during preparation or handling.

• Is this product intended for single-use only, and if so, why?

  Yes, this PBS(-) Phosphate Buffered Saline is supplied in sterile, single-use containers. The manufacturer recommends this to ensure sterility and prevent contamination, which is critical when handling sensitive biological materials like oocytes in reproductive media applications.

• How should this product be stored, and can it be used at room temperature?

  The product is intended for use in ambient atmospheric conditions, meaning it can be stored and used at room temperature without requiring refrigeration. However, it should be kept in a clean, dry environment to maintain its sterility and efficacy.

• What regulatory pathway was followed for this device, and which advisory committee was involved?

  This PBS(-) Phosphate Buffered Saline followed the traditional 510(k) clearance pathway under FDA regulations. The product was reviewed by the Obstetrics/Gynecology (OB) advisory committee, which specializes in reproductive health-related devices, ensuring its suitability for reproductive media applications.

• Are there different sizes or models available for this PBS(-) Phosphate Buffered Saline?

  The provided data does not specify distinct sizes or models for this PBS(-) Phosphate Buffered Saline, but it is supplied in sterile, single-use containers. For exact container volumes or variations, it would be best to consult the manufacturer’s product catalog or contact their technical support.