Asap Muitiscope
by asap endoscopic products GmbH
510(k) K121261
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK121261 | Date8 Jan 2013 | 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- Withdrawn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
- HRX
- Device class
- Class II
- Regulation
- 21 CFR Part 888.1100
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 23 Sep 2026
The Asap Multiscope is an endoscope, a device used for visually examining the interior of the body. It is designed to provide a clear view of internal organs and tissues, allowing for diagnostic and therapeutic procedures to be performed.
The Asap Multiscope is supplied by asap endoscopic products GmbH and has received FDA 510K authorization. It is classified under product code HRX and has been assigned the k number K121261. The device is intended for use in medical settings, with specific instructions for use provided by the manufacturer.
Other devices from asap endoscopic products GmbH
Questions
AI-generated answers, 23 Sep 2026
What is the Asap Multiscope used for?
The Asap Multiscope is used for visually examining the interior of the body, allowing for diagnostic and therapeutic procedures to be performed.
Is the Asap Multiscope supplied sterile?
The description does not specify if the Asap Multiscope is supplied sterile, it is recommended to follow the manufacturer's instructions for use.
What is the regulatory authorization for the Asap Multiscope?
The Asap Multiscope has received FDA 510K authorization, with the k number K121261.