Cleared Traditional

HEPATIC PARENCHYMAL SUCTION DISSECTOR

K850288 · Beecher Medical Diagnostic Instrumentation · General & Plastic Surgery

Mar 1985

Decision

53d

Days

Class 1

Risk

About This 510(k) Submission

K850288 is an FDA 510(k) clearance for the HEPATIC PARENCHYMAL SUCTION DISSECTOR, a Dissector, Surgical, General & Plastic Surgery (Class I — General Controls, product code GDI), submitted by Beecher Medical Diagnostic Instrumentation (Silver Spring, US). The FDA issued a Cleared decision on March 18, 1985, 53 days after receiving the submission on January 24, 1985. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number	K850288 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 24, 1985
Decision Date	March 18, 1985
Days to Decision	53 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—