510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K940903Substantially Equivalent

Tonsil Sponge, Gauze Dissector, Cylindrical Sponges

Medical Insights, Inc., Mystic CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K940903 is the FDA 510(k) clearance record for TONSIL SPONGE, GAUZE DISSECTOR, CYLINDRICAL SPONGES, a class I device, cleared for Medical Insights, Inc. on under FDA product code KBM (Dissector, Tonsil). FDA records list 4 510(k) clearances for Medical Insights, Inc., from to . As of , FDA records show no recalls naming K940903.

Clearance record

Decision date
Received
(49 days to decision)
Product code
KBM Dissector, Tonsil
Regulation
21 CFR 874.4420
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Medical Insights, Inc. 193 Whitehall Ave., Mystic CT
510(k) summary
Statement
Third party review
No

Clearances, product code KBM

Trailing 12 months

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

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