Thoracic Drainage Set, Argyle Dual

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

510(k) Number

K770920 ↗

FDA Product Code

GAZ

Device Class

Class II

Regulation

21 CFR Part 880.6740

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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See all devices from Sherwood Medical Industries →

• What is the Thoracic Drainage Set, Argyle Dual primarily used for in clinical settings?

  The Thoracic Drainage Set, Argyle Dual is designed for removing air, blood, or other fluids from the pleural cavity, chest wall, or mediastinum. It is specifically intended for post-operative or traumatic drainage management in general hospital environments, helping to facilitate recovery by maintaining proper thoracic pressure and drainage.

• Is this device meant for repeated use, or is it single-use only?

  This device is supplied as a sterile, single-use system, meaning it is intended for one-time use only on a single patient. After use, it must be discarded to maintain sterile protocols and prevent cross-contamination.

• How should I store the Thoracic Drainage Set, Argyle Dual before use?

  Since it is a sterile, single-use system, storage should follow standard sterile medical device protocols. Keep it in its original packaging, protected from moisture, dust, and direct sunlight. Ensure the packaging remains intact until immediately before use to preserve sterility.

• What regulatory pathway does this device follow, and how does that affect its use?

  The Thoracic Drainage Set, Argyle Dual is regulated under FDA 510(k) clearance (K770920) and classified under Regulation 880.6740, with a product code of GAZ. This means it has been deemed substantially equivalent to a predicate device and is approved for use in controlled clinical environments, such as hospitals, where sterile medical device protocols must be strictly followed.