MARLOW/REDDICK LAPAROSCOPIC GRASPING FORCEPS— 510(k) K913964

Name: FDA 510(k) clearance K913964
Creator: U.S. Food and Drug Administration
Published: 1991-10-23

Substantially Equivalent

Marlo Surgical Technology

FDA 510(k) clearance K913964 for MARLOW/REDDICK LAPAROSCOPIC GRASPING FORCEPS, Substantially Equivalent on 1991-10-23. Applicant: Marlo Surgical Technology. Device class: 1.

Clearance details

Applicant: Marlo Surgical Technology
Product code: Code HTD
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1991-09-05
Decision date: 1991-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Willoughby, OH, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HTD

product code HTD

Malfunction: 892
Total: 892

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.