Bite Block/Mouthpiece for Endoscopy
FDA 510(k) K915816 · Gi Supply
510(k) numberK915816
Submission
- Device name
- Bite Block/Mouthpiece for Endoscopy
- Applicant
- Gi Supply
Camp Hill, PA, US - Received
- December 30, 1991
- Decision date
- March 27, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- EOQ – Bronchoscope (Flexible Or Rigid)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.4680
- Specialty
- Ear, Nose, Throat
A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. If the device is reprocessed, reprocessing validation data for this device type must be included in a 510(k) submission. If the device is reusable, validated…
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Questions and answers
When was Bite Block/Mouthpiece for Endoscopy cleared by the FDA?
Bite Block/Mouthpiece for Endoscopy (K915816) received a 510(k) decision of Substantially Equivalent on March 27, 1992, 88 days after the submission was received.
What is the product code of K915816?
The FDA product code is EOQ – Bronchoscope (Flexible Or Rigid), a Class II (moderate risk) device regulated under 21 CFR 874.4680.