510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K864425Substantially Equivalent

Raylor(tm) Dissecting Hook

Cedar Surgical, Inc., Minnetonka MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864425 is the FDA 510(k) clearance record for RAYLOR(TM) DISSECTING HOOK, a class I device, cleared for Cedar Surgical, Inc. on under FDA product code GDG (Hook, Surgical, General & Plastic Surgery). FDA records list 17 510(k) clearances for Cedar Surgical, Inc., from to . As of , FDA records show no recalls naming K864425.

Clearance record

Decision date
Received
(32 days to decision)
Product code
GDG Hook, Surgical, General & Plastic Surgery
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Cedar Surgical, Inc. 15265 Minnetonka Blvd., Minnetonka MN
Third party review
No

Clearances, product code GDG

Trailing 12 months

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

FDA records show no clearances under product code GDG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GDG, 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