510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K964798Substantially Equivalent

Partial Ossicular Replacement Prosthesis

Anthony D. Prescott, Memphis TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K964798 is the FDA 510(k) clearance record for PARTIAL OSSICULAR REPLACEMENT PROSTHESIS, a class II device, cleared for Anthony D. Prescott on under FDA product code ETB (Prosthesis, Partial Ossicular Replacement). FDA records list one 510(k) clearance for Anthony D. Prescott. As of , FDA records show no recalls naming K964798.

Clearance record

Decision date
Received
(34 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
Anthony D. Prescott 8624 N. Lake Cove, 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