510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K161318Substantially Equivalent

Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems

Tedan Surgical Innovations, Inc., Sugar Land TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K161318 is the FDA 510(k) clearance record for Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems, a class II device, cleared for Tedan Surgical Innovations, LLC on under FDA product code GZT (Retractor, Self-Retaining, For Neurosurgery). FDA records list 4 510(k) clearances for Tedan Surgical Innovations, LLC, from to . As of , FDA records show no recalls naming K161318.

Clearance record

Decision date
Received
(313 days to decision)
Product code
GZT Retractor, Self-Retaining, For Neurosurgery
Regulation
21 CFR 882.4800
Device class
Class II
Review panel
Neurology
Applicant
Tedan Surgical Innovations, LLC 12615 W. Airport Blvd., Suite 200, Sugar Land TX
510(k) summary
Statement
Third party review
No

Clearances, product code GZT

Trailing 12 months
1 clearance under product code GZT in the twelve months to October 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GZT, 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 20261
October 20260