510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K964561Substantially Equivalent

Endolumina II Transillumination System 56Fr E-5630, 50Fr E-5030 and 40Fr E-4020, Endolumina II Detachable Tips, 56Fr, Ta

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

K964561 is the FDA 510(k) clearance record for ENDOLUMINA II TRANSILLUMINATION SYSTEM 56FR E-5630, 50FR E-5030 AND 40FR E-4020, ENDOLUMINA II DETACHABLE TIPS, 56FR, TA, a class I device, cleared for Bioenterics Corp. on under FDA product code FDG (Retractor, Fiberoptic). FDA records list 4 510(k) clearances for Bioenterics Corp., from to . As of , FDA records show no recalls naming K964561.

Clearance record

Decision date
Received
(90 days to decision)
Product code
FDG Retractor, Fiberoptic
Regulation
21 CFR 876.4530
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
Bioenterics Corp. 1035 A. Cindy Ln., Carpinteria CA
510(k) summary
Summary
Third party review
No

Clearances, product code FDG

Trailing 12 months

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

FDA records show no clearances under product code FDG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FDG, 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