510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K162321Substantially Equivalent

EasyClip Xpress

Restore Surgical, LLC dba Instratek, Houston TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K162321 is the FDA 510(k) clearance record for EasyClip Xpress, a class II device, cleared for Restore Surgical, LLC Dba Instratek on under FDA product code JDR (Staple, Fixation, Bone). FDA records list 3 510(k) clearances for Restore Surgical, LLC Dba Instratek, from to . As of , FDA records show no recalls naming K162321.

Clearance record

Decision date
Received
(175 days to decision)
Product code
JDR Staple, Fixation, Bone
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Applicant
Restore Surgical, LLC Dba Instratek 15200 Middlebrook Dr., Suite G, Houston TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JDR

Trailing 12 months
2 clearances under product code JDR in the twelve months to October 2026, August 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JDR, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20261
October 20260