Grasping Forceps OCZ
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Device Name
- Grasping Forceps EUDAMED
- Model / Reference
- NGF11-11023120 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06902284544741 EUDAMED
- Basic UDI-DI
- 6902284GF33199BL EUDAMED
- 510(k) Number
- K152802 FDA 510(k)
- FDA Product Code
- OCZ FDA 510(k)
- EMDN Code
- G03080102 GASTROINTESTINAL ENDOSCOPY, EXTRACTION FORCEPS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.1500 FDA 510(k)
- Regulation Number
- 876.1500 FDA 510(k)
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
The Grasping Forceps OCZ is an endoscopic grasping/cutting instrument, non-powered, designed for use in gastrointestinal and urological procedures. It is intended for manipulating, retrieving, and removing foreign bodies, tissue samples, or other materials within the body’s internal cavities during endoscopic examinations.
These forceps are supplied as single-use, non-sterile devices and are classified under FDA regulation 876.1500 as Class II medical devices. They are intended for use in sterile environments, such as operating rooms or endoscopy suites, and are available in multiple shaft diameters (1.8 mm, 2.3 mm, and 3.0 mm) and lengths. Authorized under FDA 510(k) clearance and MDR compliance, they are intended for retrieval and tissue manipulation in endoscopic procedures.
Frequently asked questions
Are these forceps designed for reusable procedures, or are they intended for single-use only?
These Grasping Forceps OCZ are explicitly supplied as single-use devices, even though they are non-sterile at the time of shipment. They must be used in sterile environments like operating rooms or endoscopy suites, where they are sterilized prior to use. Single-use design ensures patient safety and reduces cross-contamination risks.
What shaft sizes and lengths are available for the Grasping Forceps OCZ, and how might this affect procedure selection?
The Grasping Forceps OCZ come in three shaft diameters: 1.8 mm, 2.3 mm, and 3.0 mm, with varying lengths to accommodate different endoscopic procedures. Smaller diameters (e.g., 1.8 mm) are ideal for narrow or delicate cavities, while larger diameters (e.g., 3.0 mm) may offer better grasping strength for firmer tissue or larger foreign bodies. The choice depends on the anatomical site and procedural requirements.
How should these forceps be stored, and what precautions should be taken before use?
The Grasping Forceps OCZ are non-sterile when supplied, so they must be sterilized before use in sterile environments like operating rooms or endoscopy suites. Storage should follow manufacturer guidelines to maintain integrity—typically in a clean, dry place away from direct sunlight or extreme temperatures. Always check the packaging for expiration dates or sterility indicators if reprocessed.
What types of procedures are these forceps primarily intended for, and which medical specialties commonly use them?
These forceps are designed for gastrointestinal and urological procedures, specifically for manipulating, retrieving, or removing foreign bodies, tissue samples, or other materials during endoscopic examinations. They are most commonly used by gastroenterologists and urologists, as indicated by their FDA advisory committee classification (Gastroenterology, Urology).
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: Retrieval Grasping Forceps - Micro-Tech Endoscopy, Search Result - MICRO-TECH (Nanjing) Co., Ltd., Micro-Tech (Nanjing) Co., Ltd.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K152802 | Class II | Active |
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Manufacturer
- Manufacturer
- Micro-Tech (Nanjing) Co., Ltd.
Sources (2)
- FDA 510(k) K152802 24 fields · synced Sep 30, 2026
- EUDAMED 14151fce-3ec7-44ca-9034-2b1796246c63 61 fields · synced Sep 17, 2026