Cleared Traditional

K921167 - ULTRABLADE
(FDA 510(k) Clearance)

K921167 · Micron Technology, Inc. · General & Plastic Surgery

Jul 1992

Decision

141d

Days

Class 1

Risk

K921167 is an FDA 510(k) clearance for the ULTRABLADE, a Scalpel, One-piece (Class I — General Controls, product code GDX), submitted by Micron Technology, Inc. (Boulder, US). The FDA issued a Cleared decision on July 30, 1992, 141 days after receiving the submission on March 11, 1992. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number	K921167 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 11, 1992
Decision Date	July 30, 1992
Days to Decision	141 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Statement