510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K923355Substantially Equivalent

Pharyngeal Salivary Bypass Tube

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

K923355 is the FDA 510(k) clearance record for PHARYNGEAL SALIVARY BYPASS TUBE, a class I device, cleared for Boston Medical Products, Inc. on under FDA product code KCF (Dilator, Esophageal, Ent). FDA records list 33 510(k) clearances for Boston Medical Products, Inc., from to . As of , FDA records show no recalls naming K923355.

Clearance record

Decision date
Received
(90 days to decision)
Product code
KCF Dilator, Esophageal, Ent
Regulation
21 CFR 874.4420
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Boston Medical Products, Inc. 87 Rumford Ave., Waltham MA
510(k) summary
Statement
Third party review
No

Clearances, product code KCF

Trailing 12 months

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

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