TECNOL SECURE-ALL FETAL MONITOR STRAP— 510(k) K861189

Name: FDA 510(k) clearance K861189
Creator: U.S. Food and Drug Administration
Published: 1986-04-08

Substantially Equivalent

Tecnol New Jersey Wound Care, Inc.

FDA 510(k) clearance K861189 for TECNOL SECURE-ALL FETAL MONITOR STRAP, Substantially Equivalent on 1986-04-08. Applicant: Tecnol New Jersey Wound Care, Inc.. Device class: 2.

Clearance details

Applicant: Tecnol New Jersey Wound Care, Inc.
Product code: Code HGM
Device class: Class 2
Regulation: 21 CFR 884.2740
Advisory panel: Obstetrics/Gynecology
Date received: 1986-03-31
Decision date: 1986-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Worth, TX, US

Download summary PDF View on FDA.gov ↗

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K911907 — FLUIDSHIELD CONE CLASSIC II SURG MASK W/SPLASH VIS1991-07-08
K896193 — TECNOL LAZER(TM) SURGICAL MASK1990-02-27
K894205 — TECNOL SILK STRIP1989-07-25

Adverse events under product code HGM

product code HGM

Death: 35
Malfunction: 478
Total: 513

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.