Cleared Traditional

K964871 - BIOSEARCH SYRING FLUSHING/CLEANING PUMP FOR BIOSEARCH ENDOSCOPIC INSTRUMENTS
(FDA 510(k) Clearance)

K964871 · Biosearch Medical Products, Inc. · General Hospital

Mar 1997

Decision

88d

Days

Class 2

Risk

K964871 is an FDA 510(k) clearance for the BIOSEARCH SYRING FLUSHING/CLEANING PUMP FOR BIOSEARCH ENDOSCOPIC INSTRUMENTS. This device is classified as a Accessories, Cleaning, For Endoscope (Class II — Special Controls, product code FEB).

Submitted by Biosearch Medical Products, Inc. (Somerville, US). The FDA issued a Cleared decision on March 3, 1997, 88 days after receiving the submission on December 5, 1996.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 876.1500. 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)..

Submission Details

510(k) Number	K964871 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 05, 1996
Decision Date	March 03, 1997
Days to Decision	88 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	FEB — Accessories, Cleaning, For Endoscope
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.1500
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).