510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K924304Substantially Equivalent

Bite Block

United States Endoscopy Group, Inc., Waite Hill OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K924304 is the FDA 510(k) clearance record for BITE BLOCK, a class II device, cleared for United States Endoscopy Group, Inc. on under FDA product code JXL (Block, Bite). FDA records list 94 510(k) clearances for United States Endoscopy Group, Inc., from to . As of , FDA records show no recalls naming K924304.

Clearance record

Decision date
Received
(223 days to decision)
Product code
JXL Block, Bite
Regulation
21 CFR 882.5070
Device class
Class II
Review panel
Neurology
Applicant
United States Endoscopy Group, Inc. 9905 Hobart Rd., Waite Hill OH
510(k) summary
Statement
Third party review
No

Clearances, product code JXL

Trailing 12 months

FDA records hold no clearances under product code JXL in the trailing twelve months.

FDA records show no clearances under product code JXL in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JXL, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260