Identifiers
- 510(k) Number
- K013576 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 Periscope, Model # PERISC1, is a laparoscope designed for minimally invasive surgical procedures in general and plastic surgery. It provides visual access to internal body cavities, enabling precise inspection and manipulation during endoscopic interventions, particularly in gastroenterology and urology.
This device is supplied as a reusable medical instrument and is classified under FDA product code GCJ as a Class II device under special controls. It requires appropriate sterilisation and maintenance protocols to ensure safety and functionality. The Periscope was granted FDA 510(k) clearance under the Substantially Equivalent (SESE) determination in January 2002, adhering to regulatory standards for endoscopic visualization tools.
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: PERICSCOPE, MODEL # PERISC1 (K013576) - FDA 510 (k), PERICSCOPE, MODEL # PERISC1 510(k) K013576 - FDA.report, PERICSCOPE, MODEL # PERISC1 (K013576) — FDA 510(k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K013576 | Class II | Active |
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Manufacturer
- Manufacturer
- Ethicon Endo-Surgery, Inc.
Sources (1)
- FDA 510(k) K013576 24 fields · synced Sep 19, 2026