MONOSCOPY(TM) BRAND, TROCAR REDUCER SET— 510(k) K902563

Name: FDA 510(k) clearance K902563
Creator: U.S. Food and Drug Administration
Published: 1990-09-04

Substantially Equivalent

Dexide, Inc.

FDA 510(k) clearance K902563 for MONOSCOPY(TM) BRAND, TROCAR REDUCER SET, Substantially Equivalent on 1990-09-04. Applicant: Dexide, Inc.. Device class: 2.

Clearance details

Applicant: Dexide, Inc.
Product code: Code HET
Device class: Class 2
Regulation: 21 CFR 884.1720
Advisory panel: Obstetrics/Gynecology
Date received: 1990-06-11
Decision date: 1990-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Worth, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HET

view all

K250939 — SIRIUS Endoscope System (PR-SI-1230)2025-08-29
K243821 — i-Cut2025-04-25
K221642 — SIRIUS Endoscope System2022-12-12
K210116 — Video Endoscopy System, 3D Video Endoscopy System2021-10-13
K201832 — Endoeye Flex Deflectable Videoscope Olympus LTF-S190-52021-09-17

More clearances from Dexide, Inc.

view all

K991814 — MULTACHOICE INSTRUMENTS1999-06-23
K990379 — MODIFICATION TO MULTAPORT CANNULA, REDUCER AND ACCESSORIES1999-03-04
K981940 — MULTAPUMP DISPOSABLE PUMP HEAD AND ACCESSORIES1998-09-25
K981941 — MULTAPORT CANNULA REDUCER AND ACCESSORIES1998-07-29
K953611 — DEXIDE ENDO-LUBE KIT1995-09-15

Adverse events under product code HET

product code HET

Malfunction: 10,504
Total: 10,504

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.