Cleared Traditional

K924929 - REFLEX(R) ECA
(FDA 510(k) Clearance)

K924929 · Richard-Allan Medical · General & Plastic Surgery device

Jul 1993

Decision

294d

Days

Class 1

Risk

K924929 is an FDA 510(k) clearance for the REFLEX(R) ECA. This device is classified as a Applier, Hemostatic Clip (Class I - General Controls, product code HBT).

Submitted by Richard-Allan Medical (Richland, US). The FDA issued a Cleared decision on July 21, 1993, 294 days after receiving the submission on September 30, 1992.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number	K924929 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 30, 1992
Decision Date	July 21, 1993
Days to Decision	294 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF