Cleared Traditional

DOUBLETIME 2-TIPPED APPLIERS FOR HEMOCLI

K800318 · Edward Weck, Inc. · General & Plastic Surgery
Mar 1980
Decision
27d
Days
Class 1
Risk

About This 510(k) Submission

K800318 is an FDA 510(k) clearance for the DOUBLETIME 2-TIPPED APPLIERS FOR HEMOCLI, a Applier, Hemostatic Clip (Class I — General Controls, product code HBT), submitted by Edward Weck, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 10, 1980, 27 days after receiving the submission on February 12, 1980. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K800318 FDA.gov
FDA Decision Cleared SESE
Date Received February 12, 1980
Decision Date March 10, 1980
Days to Decision 27 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code HBT — Applier, Hemostatic Clip
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4800