DeviceClearance

Electro-Spec Steri-Caps— 510(k) K231905

Substantially Equivalent

Electro-Spec, Inc.

FDA 510(k) clearance K231905 for Electro-Spec Steri-Caps, Substantially Equivalent on 2023-08-14. Applicant: Electro-Spec, Inc.. Device class: 2.

Clearance details

Applicant
Electro-Spec, Inc.
Product code
Code HTY
Device class
Class 2
Regulation
21 CFR 888.3040
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Franklin, IN, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code HTY

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Adverse events under product code HTY

product code HTY
Injury
544
Total
544

Source: openFDA MAUDE database, through . 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.