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ReliaCatch Specimen Retrieval Bag 10mm; ReliaCatch Specimen Retrieval Bag 12mm

FDA 510(k)

Class II (US FDA 510(k))

510(k) K163102

by Covidien

Identifiers

510(k) Number
K163102 FDA 510(k)
FDA Product Code
GCJ FDA 510(k)
Models / Variants
ReliaCatch Specimen Retrieval Bag 10mm FDA 510(k)
ReliaCatch Specimen Retrieval Bag 12mm FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.1500 FDA 510(k)
Regulation Number
876.1500 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The ReliaCatch Specimen Retrieval Bag is a sterile, single-use device designed for the retrieval and containment of surgical specimens. It is classified as a specimen retrieval bag, featuring a reinforced structure to ensure secure encapsulation of excised tissue or material during minimally invasive or open surgical procedures.

This device is supplied sterile in a sealed package and intended for one-time use. It is available in two sizes, 10mm and 12mm, with a volume capacity of 275 mL, and is intended for use in surgical settings. The ReliaCatch Specimen Retrieval Bag holds an FDA 510(k) clearance under the product code GCJ, with a decision classification of Substantially Equivalent.

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: ReliaCatch™ Specimen Retrieval Bag | Medtronic Animal Health, Covidien ReliaCatch Specimen Retrieval Bag 10 mm - CATCH 10, Specimen Retrieval Products | Medtronic Animal Health

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Covidien

Sources (1)

  • FDA 510(k) K163102 24 fields · synced Sep 19, 2026