Acclarent Cyclops Multi-Angle Endoscope
FDA 510(k) K110097 · Acclarent, Inc.
510(k) numberK110097
Submission
- Device name
- Acclarent Cyclops Multi-Angle Endoscope
- Applicant
- Acclarent, Inc.
Rmenlo Park, CA, US - Received
- January 13, 2011
- Decision date
- May 27, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- EOB – Nasopharyngoscope (Flexible Or Rigid)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.4760
- Specialty
- Ear, Nose, Throat
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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Questions and answers
When was Acclarent Cyclops Multi-Angle Endoscope cleared by the FDA?
Acclarent Cyclops Multi-Angle Endoscope (K110097) received a 510(k) decision of Substantially Equivalent on May 27, 2011, 134 days after the submission was received.
What is the product code of K110097?
The FDA product code is EOB – Nasopharyngoscope (Flexible Or Rigid), a Class II (moderate risk) device regulated under 21 CFR 874.4760.