510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K953673Substantially Equivalent

Eclipse Probe Cover

Parker Laboratories, Inc., Orange NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K953673 is the FDA 510(k) clearance record for ECLIPSE PROBE COVER, a class II device, cleared for Parker Laboratories, Inc. on under FDA product code IYO (System, Imaging, Pulsed Echo, Ultrasonic). FDA records list 30 510(k) clearances for Parker Laboratories, Inc., from to . As of , FDA records show one recall naming K953673.

Clearance record

Decision date
Received
(220 days to decision)
Product code
IYO System, Imaging, Pulsed Echo, Ultrasonic
Regulation
21 CFR 892.1560
Device class
Class II
Review panel
Radiology
Applicant
Parker Laboratories, Inc. 307 Washington St., Orange NJ
510(k) summary
Statement
Third party review
No

Clearances, product code IYO

Trailing 12 months
8 clearances under product code IYO in the twelve months to October 2026, February 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code IYO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20262
March 20261
April 20262
May 20260
June 20261
July 20261
August 20260
September 20261
October 20260