510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K994191Substantially Equivalent

Spetzler Round Handle Appliers, Models C-3753, C-3753T, C-3754, C-3754T

Nmt Medical, Inc., Marietta GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K994191 is the FDA 510(k) clearance record for SPETZLER ROUND HANDLE APPLIERS, MODELS C-3753, C-3753T, C-3754, C-3754T, a class II device, cleared for Nmt Medical, Inc. on under FDA product code HCI (Applier, Aneurysm Clip). FDA records list 2 510(k) clearances for Nmt Medical, Inc., from to . As of , FDA records show no recalls naming K994191.

Clearance record

Decision date
Received
(57 days to decision)
Product code
HCI Applier, Aneurysm Clip
Regulation
21 CFR 882.4175
Device class
Class II
Review panel
Neurology
Applicant
Nmt Medical, Inc. 1733 Canton Ln., Marietta GA
510(k) summary
Summary
Third party review
No

Clearances, product code HCI

Trailing 12 months

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

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