510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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MNKClass I

Endoscopic Bite Block

21 CFR 876.1500 / Gastroenterology, Urology
FDA source (opens on fda.gov)

MNK is the FDA product code for Endoscopic Bite Block, a class I device type, regulated under 21 CFR 876.1500. FDA's definition for this code reads: "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". As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
MNK
Device name
Endoscopic Bite Block
FDA 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.
Regulation
21 CFR 876.1500
Device class
Class I
Review panel
Gastroenterology, Urology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
6
Ingested recalls
0

Clearances, product code MNK

By decision year
6 clearances under product code MNK with a decision year between 1990 and 1994, 1993 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code MNK by decision year
YearClearances
19901
19921
19932
19942

Applicants with the most clearances

Product code MNK
Applicants holding the most 510(k) clearances under product code MNK
ApplicantClearances
Encompas Unlimited, Inc.1
Endoscopix1
Endovations1
Gi Supply1
Stantex Pty, Ltd.1
Superior Healthcare Group, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 117 companies shown, in name order