510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K844352Substantially Equivalent

Sundt-Kees Reinforcing Aneurysm Clip

Kees Surgical Specialty Co., Inc., Wilder KY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K844352 is the FDA 510(k) clearance record for SUNDT-KEES REINFORCING ANEURYSM CLIP, a class II device, cleared for Kees Surgical Specialty Co., Inc. on under FDA product code HCH (Clip, Aneurysm). FDA records list one 510(k) clearance for Kees Surgical Specialty Co., Inc. As of , FDA records show no recalls naming K844352.

Clearance record

Decision date
Received
(76 days to decision)
Product code
HCH Clip, Aneurysm
Regulation
21 CFR 882.5200
Device class
Class II
Review panel
Neurology
Applicant
Kees Surgical Specialty Co., Inc. 104 N. St., Wilder KY
Third party review
No

Clearances, product code HCH

Trailing 12 months

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

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