Cleared Traditional

K933508 - REFLEX SDD SURGICAL STAPLER
(FDA 510(k) Clearance)

K933508 · Richard-Allan Medical · General & Plastic Surgery device

Nov 1993

Decision

126d

Days

Class 1

Risk

K933508 is an FDA 510(k) clearance for the REFLEX SDD SURGICAL STAPLER. This device is classified as a Applier, Staple, Surgical, (Class I - General Controls, product code GEF).

Submitted by Richard-Allan Medical (Richland, US). The FDA issued a Cleared decision on November 23, 1993, 126 days after receiving the submission on July 20, 1993.

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

Submission Details

510(k) Number	K933508 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 20, 1993
Decision Date	November 23, 1993
Days to Decision	126 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF