510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K802915Substantially Equivalent

Montg. Tracheal Trephine Fene Strator

Boston Medical Products, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K802915 is the FDA 510(k) clearance record for MONTG. TRACHEAL TREPHINE FENE STRATOR, a class I device, cleared for Boston Medical Products, Inc. on under FDA product code KBF (Trephine, Sinus). FDA records list 33 510(k) clearances for Boston Medical Products, Inc., from to . As of , FDA records show no recalls naming K802915.

Clearance record

Decision date
Received
(30 days to decision)
Product code
KBF Trephine, Sinus
Regulation
21 CFR 874.4420
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Boston Medical Products, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KBF

Trailing 12 months

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

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