Endoscopic Bite Block

MNK · Class I — Low Risk (general controls) · Gastroenterology, Urology · 21 CFR 876.1500

Classification

FDA Product Code: MNK
Device class: Class I — Low Risk (general controls)
Regulation: 21 CFR 876.1500
Review panel: GU
Medical specialty: Gastroenterology, Urology
Submission type: 4
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

To prevent patient from biting down in order to protect fragile endoscope equipment, patient's teeth and gums, and endscopist's fingers when inserting endoscope orally.

Market data

Cleared 510(k) submissions: 6
Registered establishments: 124

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown