Cleared Traditional

CELL-MATE(TM) MASS CYTOLOGY-CELLULAR RETRIEVAL SYST

K934193 · Biosearch Medical Products, Inc. · Ear, Nose, Throat

Nov 1993

Decision

85d

Days

Class 2

Risk

About This 510(k) Submission

K934193 is an FDA 510(k) clearance for the CELL-MATE(TM) MASS CYTOLOGY-CELLULAR RETRIEVAL SYST, a Esophagoscope (flexible Or Rigid) (Class II — Special Controls, product code EOX), submitted by Biosearch Medical Products, Inc. (Somerville, US). The FDA issued a Cleared decision on November 19, 1993, 85 days after receiving the submission on August 26, 1993. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4710.

Submission Details

510(k) Number	K934193 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 26, 1993
Decision Date	November 19, 1993
Days to Decision	85 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Statement

Device Classification

Product Code	EOX — Esophagoscope (flexible Or Rigid)
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 874.4710
Definition	If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).