WRENCH— 510(k) K791073

Name: FDA 510(k) clearance K791073
Creator: U.S. Food and Drug Administration
Published: 1979-06-20

Substantially Equivalent

Truth, Inc.

FDA 510(k) clearance K791073 for WRENCH, Substantially Equivalent on 1979-06-20. Applicant: Truth, Inc.. Device class: 1.

Clearance details

Applicant: Truth, Inc.
Product code: Code HXC
Device class: Class 1
Regulation: 21 CFR 888.4540
Advisory panel: Orthopedic
Date received: 1979-06-12
Decision date: 1979-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HXC

view all

K180092 — Intellitorq2018-03-08
K874358 — COMBINATION WRENCHES1987-11-23
K874359 — ADJUSTABLE WRENCHES1987-11-23
K870053 — TORQUEDRIVER WRENCH1987-03-11
K813067 — SPINAL WRENCH1981-11-24

Adverse events under product code HXC

product code HXC

Malfunction: 851
Total: 851

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.