ORTHOPEDIC PADDING— 510(k) K802795

Name: FDA 510(k) clearance K802795
Creator: U.S. Food and Drug Administration
Published: 1980-12-10

Substantially Equivalent

Secol Co.

FDA 510(k) clearance K802795 for ORTHOPEDIC PADDING, Substantially Equivalent on 1980-12-10. Applicant: Secol Co.. Device class: 1.

Clearance details

Applicant: Secol Co.
Product code: Code KGX
Device class: Class 1
Regulation: 21 CFR 880.5240
Advisory panel: General Hospital
Date received: 1980-11-04
Decision date: 1980-12-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Secol Co.

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K802790 — SOLVALINE1981-02-13
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K810109 — METAL SPLINTS1981-01-26
K810110 — COBBLER'S CHIP SPLINTS1981-01-26
K802794 — PRO-OPHTA STICKS1980-12-22

Adverse events under product code KGX

product code KGX

Injury: 1,590
Malfunction: 1,357
Other: 3
Total: 2,950

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.