Optus Thoracoscopes
by Optus, Inc.
510(k) K945263
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK945263 | Date13 Dec 1994 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- GCJ
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.1500
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 24 Sep 2026
The Optus Thoracoscopes are a type of medical device used for thoracoscopy. They are designed to provide visualization of the thoracic cavity. The device is classified under the product code GCJ.
The Optus Thoracoscopes are supplied by Optus, Inc. and have received FDA 510(k) clearance, with a decision date of December 13, 1994, and K number K945263. The device was found to be substantially equivalent.
Other devices from Optus, Inc.
Questions
AI-generated answers, 24 Sep 2026
What is the Optus Thoracoscopes device used for?
The Optus Thoracoscopes are used for thoracoscopy to provide visualization of the thoracic cavity, aiding in medical procedures.
How is the Optus Thoracoscopes device supplied?
The Optus Thoracoscopes are supplied by Optus, Inc.
What is the regulatory status of the Optus Thoracoscopes?
The Optus Thoracoscopes have received FDA 510(k) clearance, indicating they are substantially equivalent to a predicate device.