FLEXIBLE GRASPING FORCEPS— 510(k) K854112

Name: FDA 510(k) clearance K854112
Creator: U.S. Food and Drug Administration
Published: 1986-03-12

Substantially Equivalent

Hood Laboratories

FDA 510(k) clearance K854112 for FLEXIBLE GRASPING FORCEPS, Substantially Equivalent on 1986-03-12. Applicant: Hood Laboratories. Device class: 2.

Clearance details

Applicant: Hood Laboratories
Product code: Code EWL
Device class: Class 2
Regulation: 21 CFR 874.3730
Advisory panel: Ear, Nose, Throat
Date received: 1985-10-08
Decision date: 1986-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pembroke, MA, US

Download summary PDF View on FDA.gov ↗

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K093258 — BLOM-SINGER INDWELLING TEP OCCLUDER2010-03-03

More clearances from Hood Laboratories

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K921452 — ACOUSTIC RHINOMETER1993-07-08
K920994 — HOOD NASAL SEPTAL BUTTON1992-05-15
K905703 — KRUPIN EYE VALVE WITH DISK1991-03-15
K904821 — ELIACHAR MODIFIED ESOPHAGEAL STENT1991-01-14
K897049 — GIBSON ENDOLYMPHATIC SHUNT1990-03-16

Adverse events under product code EWL

product code EWL

Death: 2
Total: 2

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.