510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K860558Substantially Equivalent

Esophageal Stethoscope

Sharn, Inc., Tampa FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K860558 is the FDA 510(k) clearance record for ESOPHAGEAL STETHOSCOPE, a class I device, cleared for Sharn, Inc. on under FDA product code BZW (Stethoscope, Esophageal). FDA records list 3 510(k) clearances for Sharn, Inc., from to . As of , FDA records show no recalls naming K860558.

Clearance record

Decision date
Received
(46 days to decision)
Product code
BZW Stethoscope, Esophageal
Regulation
21 CFR 868.1910
Device class
Class I
Review panel
Anesthesiology
Applicant
Sharn, Inc. 1300 N. Westshore Blvd., Tampa FL
Third party review
No

Clearances, product code BZW

Trailing 12 months

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

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