Identifiers
- 510(k) Number
- K060534 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 Intuitive Surgical Seal is a device that has been determined to be substantially equivalent to a predicate device under the FDA 510(k) process. It is identified by the product code GCJ and was cleared under the special 510(k) pathway with decision code SESE.
The device was manufactured by Applied Medical Resources Corp. and received FDA clearance on March 13, 2006, under k-number K060534. It is associated with the Gastroenterology and Urology advisory committees and was reviewed under the SU review advisory committee classification.
Frequently asked questions
What is the Intuitive Surgical Seal used for?
The Intuitive Surgical Seal is a device cleared under FDA 510(k) as substantially equivalent to a predicate, associated with gastroenterology and urology advisory committees, indicating its intended use aligns with those clinical specialties based on its regulatory classification.
How was the Intuitive Surgical Seal cleared for market?
The device received FDA clearance through the special 510(k) pathway on March 13, 2006, under k-number K060534, following a determination of substantial equivalence to a predicate device with product code GCJ and decision code SESE.
Who manufactures the Intuitive Surgical Seal and where is it located?
The Intuitive Surgical Seal is manufactured by Applied Medical Resources Corp., located at 22872 Avenida Empresa, Rancho Santa, CA 92688, United States, as specified in the device’s authorization and address details.
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: INTUITIVE SURGICAL SEAL 510(k) K060534 - FDA.report, Intuitive | Maker of Da Vinci & Ion Robotic Systems, INTUITIVE SURGICAL SEAL (K060534) — FDA 510(k) | Innolitics, Offene Stellen in Freiburg, Deutschland | Offene Stellen bei Intuitive, PDF K060534 INTUITIVE SURGICAL SEAL - 510kdatabase.net
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K060534 | Class II | Active |
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Manufacturer
- Manufacturer
- Applied Medical Resources Corp.
Sources (1)
- FDA 510(k) K060534 24 fields · synced Oct 1, 2026