510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K953516Substantially Equivalent for Some Indications

Medcomp Mc 5 Gradient Sequential Pump

Yoav Gershoni, Gaithersburg MD / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K953516 is the FDA 510(k) clearance record for MEDCOMP MC 5 GRADIENT SEQUENTIAL PUMP, a class II device, cleared for Yoav Gershoni on under FDA product code IRP (Massager, Powered Inflatable Tube). FDA records list one 510(k) clearance for Yoav Gershoni. As of , FDA records show no recalls naming K953516.

Clearance record

Decision date
Received
(135 days to decision)
Product code
IRP Massager, Powered Inflatable Tube
Regulation
21 CFR 890.5650
Device class
Class II
Review panel
Physical Medicine
Applicant
Yoav Gershoni 19636 Club House Rd., Gaithersburg MD
Third party review
No

Clearances, product code IRP

Trailing 12 months
11 clearances under product code IRP in the twelve months to October 2026, April 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code IRP, trailing twelve months
MonthClearances
November 20251
December 20250
January 20261
February 20260
March 20260
April 20263
May 20262
June 20261
July 20262
August 20261
September 20260
October 20260