ENDOSCOPIC NEEDLEHOLDER, MODIFICATION— 510(k) K930330

Name: FDA 510(k) clearance K930330
Creator: U.S. Food and Drug Administration
Published: 1993-06-08

Substantially Equivalent

Holmed Corp.

FDA 510(k) clearance K930330 for ENDOSCOPIC NEEDLEHOLDER, MODIFICATION, Substantially Equivalent on 1993-06-08. Applicant: Holmed Corp.. Device class: 1.

Clearance details

Applicant: Holmed Corp.
Product code: Code FHQ
Device class: Class 1
Regulation: 21 CFR 876.4730
Advisory panel: Gastroenterology, Urology
Date received: 1993-01-22
Decision date: 1993-06-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Easton, MA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FHQ

product code FHQ

Other: 1
Total: 1

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.