CONCEPT UNIVERSAL PUMP SYSTEM— 510(k) K933873

Name: FDA 510(k) clearance K933873
Creator: U.S. Food and Drug Administration
Published: 1994-12-29

Substantially Equivalent

Linvatec Corp.

FDA 510(k) clearance K933873 for CONCEPT UNIVERSAL PUMP SYSTEM, Substantially Equivalent on 1994-12-29. Applicant: Linvatec Corp.. Device class: 2.

Clearance details

Applicant: Linvatec Corp.
Product code: Code HIG
Device class: Class 2
Regulation: 21 CFR 884.1700
Advisory panel: Obstetrics/Gynecology
Date received: 1993-08-09
Decision date: 1994-12-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Largo, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HIG

view all

K261706 — Endomat Select (UP220)2026-07-16
K251273 — Asurys Fluid Management System2026-03-27
K240886 — Fluent Pro Fluid Management System (FLT-200) +4 more2024-07-25
K210628 — X-FLO Fluid Management System2021-11-04
K201355 — Endomat Select, IBS Shaver Software, License2020-07-22

More clearances from Linvatec Corp.

view all

Adverse events under product code HIG

product code HIG

Death: 8
Other: 2
Total: 10

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.