510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K953763Substantially Equivalent

Gladiator Antishock Pants

Jobst Institute, Inc., Charlotte NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K953763 is the FDA 510(k) clearance record for GLADIATOR ANTISHOCK PANTS, a class II device, cleared for Jobst Institute, Inc. on under FDA product code LHX (Trousers, Anti-Shock). FDA records list 15 510(k) clearances for Jobst Institute, Inc., from to . As of , FDA records show no recalls naming K953763.

Clearance record

Decision date
Received
(109 days to decision)
Product code
LHX Trousers, Anti-Shock
Regulation
21 CFR 870.5800
Device class
Class II
Review panel
Cardiovascular
Applicant
Jobst Institute, Inc. 5825 Carnegie Blvd., Charlotte NC
510(k) summary
Summary
Third party review
No

Clearances, product code LHX

Trailing 12 months

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

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