UNIMAX VERESS NEEDLE— 510(k) K111441

Name: FDA 510(k) clearance K111441
Creator: U.S. Food and Drug Administration
Published: 2011-08-19

Substantially Equivalent

Unimax Medical Systems, Inc.

FDA 510(k) clearance K111441 for UNIMAX VERESS NEEDLE, Substantially Equivalent on 2011-08-19. Applicant: Unimax Medical Systems, Inc.. Device class: 2.

Clearance details

Applicant: Unimax Medical Systems, Inc.
Product code: Code HIF
Device class: Class 2
Regulation: 21 CFR 884.1730
Advisory panel: Obstetrics/Gynecology
Date received: 2011-05-24
Decision date: 2011-08-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei County, TW

Download summary PDF View on FDA.gov ↗

Recent devices under product code HIF

view all

K260209 — ENDOFLATOR+; Smart Smoke Evacuation2026-08-19
K252584 — Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C)2026-06-25
K252318 — Insufflator (OPTO-IFL1000)2026-04-16
K250388 — ENDOFLATOR +2025-09-22
K242772 — AirSurgN Insufflator (10030/AirSurgN)2025-04-11

More clearances from Unimax Medical Systems, Inc.

view all

K211577 — SoftFix Balloon Trocar2021-11-05
K103508 — UNMIAX LAPAROSCOPIC INSTRUMENT2011-12-20
K112358 — UNIMAX TROCAR SYSTEM2011-10-17
K111622 — UNIMAX ANTI-FOG SOLUTION2011-09-09
K103509 — UNIMAX SUCTION IRRIGATION SET2011-05-19

Adverse events under product code HIF

product code HIF

Death: 19
Injury: 578
Malfunction: 5,639
Total: 6,236

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.