510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K952200Substantially Equivalent

Omni-Jug

Waterstone Medical, Inc., Bethesda MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K952200 is the FDA 510(k) clearance record for OMNI-JUG, a class I device, cleared for Waterstone Medical, Inc. on under FDA product code KDG (Chisel (Osteotome)). FDA records list one 510(k) clearance for Waterstone Medical, Inc. As of , FDA records show no recalls naming K952200.

Clearance record

Decision date
Received
(50 days to decision)
Product code
KDG Chisel (Osteotome)
Regulation
21 CFR 878.4820
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Waterstone Medical, Inc. 7200 Wisconsin Ave., Suite 312, Bethesda MD
510(k) summary
Statement
Third party review
No

Clearances, product code KDG

Trailing 12 months

FDA records hold no clearances under product code KDG in the trailing twelve months.

FDA records show no clearances under product code KDG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KDG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260