510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K831995Substantially Equivalent

Trendo-Scope

Gabriel Ent., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K831995 is the FDA 510(k) clearance record for TRENDO-SCOPE, a class II device, cleared for Gabriel Ent. on under FDA product code HCS (Device, Temperature Measurement, Direct Contact, Powered). FDA records list 2 510(k) clearances for Gabriel Ent., from to . As of , FDA records show no recalls naming K831995.

Clearance record

Decision date
Received
(48 days to decision)
Product code
HCS Device, Temperature Measurement, Direct Contact, Powered
Regulation
21 CFR 882.1570
Device class
Class II
Review panel
Neurology
Applicant
Gabriel Ent. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code HCS

Trailing 12 months

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

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