510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K972737Substantially Equivalent

Causse Piston

Mednet Locator, Inc., Memphis TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K972737 is the FDA 510(k) clearance record for CAUSSE PISTON, a class II device, cleared for Mednet Locator, Inc. on under FDA product code ETB (Prosthesis, Partial Ossicular Replacement). FDA records list 9 510(k) clearances for Mednet Locator, Inc., from to . As of , FDA records show no recalls naming K972737.

Clearance record

Decision date
Received
(45 days to decision)
Product code
ETB Prosthesis, Partial Ossicular Replacement
Regulation
21 CFR 874.3450
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Mednet Locator, Inc. 7000 Shadow Oaks, Memphis TN
510(k) summary
Statement
Third party review
No

Clearances, product code ETB

Trailing 12 months
2 clearances under product code ETB in the twelve months to October 2026, April 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code ETB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20262
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260