Unimicro Disposable Retrieval Endo-Pouch
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K141593 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 Unimicro Disposable Retrieval Endo-Pouch is a medical device designed for the collection and extraction of tissue, organs, and calculi. It is intended for use during general and laparoscopic surgical procedures.
This device is supplied as a single-use, disposable product. It has received FDA 510(k) clearance under K141593.
Frequently asked questions
What is the intended use of the Unimicro Retrieval Endo-Pouch?
This device is specifically designed for the collection and extraction of tissue, organs, and calculi. It is intended to be used by clinicians during general and laparoscopic surgical procedures.
Is this device intended for multiple uses?
No, the Unimicro Retrieval Endo-Pouch is supplied as a single-use, disposable product. It should not be reused, as it is designed to be discarded after a single surgical procedure to maintain safety and performance standards.
What is the regulatory status of this device?
The Unimicro Disposable Retrieval Endo-Pouch has received FDA 510(k) clearance under K141593. This indicates that the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices.
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: UNIMICRO DISPOSABLE RETRIEVAL ENDO-POUCH (K141593) — FDA 510(k ..., Laparoscopic surgery-trocar-retrieval pouch-suction irrigation-Unimicro ..., UNIMICRO DISPOSABLE RETRIEVAL ENDO-POUCH 510(k) K141593 - fda.report, Disposable Retrieval Pouch-Unimicro Medical Systems (Shenzhen) Co., Ltd.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K141593 | Class II | Active |
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Manufacturer
- Manufacturer
- Unimicro Medical Systems (shenzhen) Co., Ltd.
Sources (1)
- FDA 510(k) K141593 24 fields · synced Sep 27, 2026