Cleared Traditional

DISPO-URETTE

K860796 · Roland J. Zwick, Inc. · Obstetrics & Gynecology
Apr 1986
Decision
35d
Days
Class 2
Risk

About This 510(k) Submission

K860796 is an FDA 510(k) clearance for the DISPO-URETTE, a Sampler, Endocervical (Class II — Special Controls, product code PCF), submitted by Roland J. Zwick, Inc. (Palo Alto, US). The FDA issued a Cleared decision on April 8, 1986, 35 days after receiving the submission on March 4, 1986. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1050.

Submission Details

510(k) Number K860796 FDA.gov
FDA Decision Cleared SESE
Date Received March 04, 1986
Decision Date April 08, 1986
Days to Decision 35 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary —

Device Classification

Product Code PCF — Sampler, Endocervical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.1050
Definition Obtains Tissue Samples From The Endocervical Canal For Histological Analysis.