510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K955064Substantially Equivalent

Spetzler Ti 100 Aneurysm Clip

Elekta Instruments, Inc., Atlanta GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K955064 is the FDA 510(k) clearance record for SPETZLER TI 100 ANEURYSM CLIP, a class II device, cleared for Elekta Instruments, Inc. on under FDA product code HCH (Clip, Aneurysm). FDA records list 8 510(k) clearances for Elekta Instruments, Inc., from to . As of , FDA records show no recalls naming K955064.

Clearance record

Decision date
Received
(346 days to decision)
Product code
HCH Clip, Aneurysm
Regulation
21 CFR 882.5200
Device class
Class II
Review panel
Neurology
Applicant
Elekta Instruments, Inc. 8 Executive Park W., Atlanta GA
510(k) summary
Summary
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