Cleared Traditional

STA-CLEAR ALCOHOL-FREE ENDOSCOPIC ANTI-FOG KIT

K952678 · Avail-Southwest Division · General & Plastic Surgery
Jul 1995
Decision
28d
Days
Class 1
Risk

About This 510(k) Submission

K952678 is an FDA 510(k) clearance for the STA-CLEAR ALCOHOL-FREE ENDOSCOPIC ANTI-FOG KIT, a Chisel (osteotome) (Class I — General Controls, product code KDG), submitted by Avail-Southwest Division (Dallas, US). The FDA issued a Cleared decision on July 10, 1995, 28 days after receiving the submission on June 12, 1995. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4820.

Submission Details

510(k) Number K952678 FDA.gov
FDA Decision Cleared SESE
Date Received June 12, 1995
Decision Date July 10, 1995
Days to Decision 28 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

Product Code KDG — Chisel (osteotome)
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4820