Unimax Specimen Retrieval System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K103510 FDA 510(k)
- FDA Product Code
- GCJ 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 Unimax Specimen Retrieval System is a sterile, single-use device classified as a Specimen Container (Product Code GCJ) under FDA nomenclature. It is designed for retrieving biopsy or surgical specimens during endoscopic procedures, ensuring safe containment and retrieval of tissue samples for pathological examination.
The system is supplied in a dispensing tube for easy insertion through a standard 10 mm trocar port. It is intended for single-use only and must be handled as a sterile medical device. The device holds FDA 510(k) clearance (K103510) under the Gastroenterology and Urology advisory committees, with no third-party review. Storage and handling comply with standard sterile single-use medical device protocols.
Frequently asked questions
What is the Unimax Specimen Retrieval System used for?
The Unimax Specimen Retrieval System is designed specifically for retrieving biopsy or surgical tissue samples during endoscopic procedures. Its purpose is to provide a sterile, contained method for safely collecting specimens, ensuring they remain intact and uncontaminated for accurate pathological examination.
How is the Unimax Specimen Retrieval System supplied and inserted?
The system comes pre-packaged in a sterile dispensing tube, which allows for easy insertion through a standard 10 mm trocar port. This design simplifies the retrieval process during endoscopic procedures, ensuring minimal disruption to the workflow.
Is the Unimax Specimen Retrieval System reusable or single-use?
This device is intended for single-use only and must be treated as a sterile medical instrument. Reuse could compromise sterility and compromise specimen integrity, posing risks to both patient safety and diagnostic accuracy.
What storage and handling guidelines apply to the Unimax Specimen Retrieval System?
As a sterile, single-use device, it must be stored according to standard sterile medical device protocols. Keep the dispensing tube sealed until use, and avoid exposure to contaminants or moisture. Follow manufacturer instructions for proper disposal after a single use.
Does the Unimax Specimen Retrieval System require any special regulatory approvals?
The device holds FDA 510(k) clearance (K103510) under the Gastroenterology and Urology advisory committees, classified as substantially equivalent to a predicate device. No third-party review was involved in this clearance process.
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: Unimax Medical Systems Inc., PDF 3 10 M AY -62011 - accessdata.fda.gov, Unimax Medical – Hersteller für Einweg-PSA & Medizinprodukte, ProductS | UNIMAX MEDICAL SYSTEMS INC.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K103510 | Class II | Active |
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Manufacturer
- Manufacturer
- Unimax Medical Systems Inc.
- FDA Applicant
- Unimax Medical Systems, Inc.
Sources (1)
- FDA 510(k) K103510 24 fields · synced Oct 5, 2026