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Exmoor Zoellner Sucker Ends

FDA 510(k)

Class II (US FDA 510(k))

510(k) K864937

by Exmoor Plastics , Ltd.

Identifiers

510(k) Number
K864937 FDA 510(k)
FDA Product Code
JOL FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.6740 FDA 510(k)
Regulation Number
880.6740 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Exmoor Zoellner Sucker Ends are a type of surgical suction device designed for use in otolaryngology procedures. These disposable, flexible suction tips facilitate the removal of fluids, debris, or secretions from the ear, nose, or throat during surgical interventions, ensuring clear visibility and optimal operating conditions.

These suction ends are supplied as single-use, sterile devices intended for use in hospital or clinical settings. They are classified under product code JOL and are manufactured by Exmoor Plastics, Ltd. in Taunton, UK. The device holds FDA 510(k) clearance (K864937) under the Traditional pathway, with a decision date of March 30, 1987, and is intended for general hospital use as per the advisory committee classification.

Frequently asked questions

What types of surgical procedures are these suction tips designed for, and why are they particularly useful in those settings?

The Exmoor Zoellner Sucker Ends are specifically designed for otolaryngology procedures, which involve the ear, nose, and throat. They are flexible and disposable, making them ideal for removing fluids, debris, or secretions during surgery. This ensures clear visibility for the surgeon and maintains optimal operating conditions by keeping the surgical field dry and unobstructed.

Are these suction tips reusable, or are they intended for single-use only? How does this affect their use in clinical settings?

These suction tips are explicitly labeled as disposable and intended for single-use only. This design choice reduces the risk of cross-contamination between patients, simplifies sterilization concerns, and aligns with best practices for surgical instruments in hospital or clinical settings.

What does the FDA 510(k) clearance (K864937) mean for clinicians or facilities considering this product?

The FDA 510(k) clearance (K864937) confirms that the Exmoor Zoellner Sucker Ends have been reviewed and deemed substantially equivalent to a legally marketed device already on the market. This means the product meets FDA safety and performance standards for its intended use in general hospital settings, particularly for otolaryngology procedures. It does not imply any specific clinical indication but rather validates the device’s regulatory compliance.

How should these suction tips be stored, and what precautions should be taken to maintain their sterility?

Since these are sterile, single-use devices, they should be stored in their original packaging until ready for use. The packaging is designed to preserve sterility, so it should remain unopened until immediately before use. Facilities should follow standard sterile instrument handling protocols, such as keeping them in a clean, dry environment away from direct sunlight or extreme temperatures to prevent contamination or degradation.

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: K942746 - SUCKER ENDS (ZOELLNER) | FDA 510 (k), SUCKER ENDS (ZOELLNER) (K942746) — FDA 510 (k) | Innolitics, PDF K942746 - Sucker Ends (Zoellner), Exmoor Plastics , Ltd. · DeviceClearance, 510(k) Premarket Notification

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Exmoor Plastics , Ltd.

Sources (1)

  • FDA 510(k) K864937 24 fields · synced Sep 19, 2026