510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K896205Substantially Equivalent

Monoscopy Brand, 5 Mm Locking Trocar Sleeve

Dexide, Inc., Fort Worth TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K896205 is the FDA 510(k) clearance record for MONOSCOPY BRAND, 5 MM LOCKING TROCAR SLEEVE, a class II device, cleared for Dexide, Inc. on under FDA product code GCI (Laryngoscope, Endoscope). FDA records list 38 510(k) clearances for Dexide, Inc., from to . As of , FDA records show no recalls naming K896205.

Clearance record

Decision date
Received
(147 days to decision)
Product code
GCI Laryngoscope, Endoscope
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Dexide, Inc. P.O. Box 185789, Fort Worth TX
Third party review
No

Clearances, product code GCI

Trailing 12 months

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

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