510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K934084Substantially Equivalent

Bioenterics Endolumina Illuminating Bougie

Bioenterics Corp., Carpinteria CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K934084 is the FDA 510(k) clearance record for BIOENTERICS ENDOLUMINA ILLUMINATING BOUGIE, a class I device, cleared for Bioenterics Corp. on under FDA product code HMJ (Screen, Tangent, Projection, Battery-Powered). FDA records list 4 510(k) clearances for Bioenterics Corp., from to . As of , FDA records show no recalls naming K934084.

Clearance record

Decision date
Received
(118 days to decision)
Product code
HMJ Screen, Tangent, Projection, Battery-Powered
Regulation
21 CFR 886.1810
Device class
Class I
Review panel
Ophthalmic
Applicant
Bioenterics Corp. 1035 A. Cindy Ln., Carpinteria CA
510(k) summary
Statement
Third party review
No

Clearances, product code HMJ

Trailing 12 months

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

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