510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K914749Substantially Equivalent

Wavicide(r) -01

Wave Energy Systems, Inc., Cedar Grove NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K914749 is the FDA 510(k) clearance record for WAVICIDE(R) -01, a class II device, cleared for Wave Energy Systems, Inc. on under FDA product code MED (Sterilant, Medical Devices). FDA records list one 510(k) clearance for Wave Energy Systems, Inc. As of , FDA records show no recalls naming K914749.

Clearance record

Decision date
Received
(1,388 days to decision)
Product code
MED Sterilant, Medical Devices
Regulation
21 CFR 880.6885
Device class
Class II
Review panel
General Hospital
Applicant
Wave Energy Systems, Inc. 218 Little Falls Rd., Cedar Grove NJ
510(k) summary
Statement
Third party review
No

Clearances, product code MED

Trailing 12 months
1 clearance under product code MED in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MED, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260