Cleared Traditional

K822254 - ELECTRIC CORD FOR ENDOSCOPE
(FDA 510(k) Clearance)

K822254 · Kelleher Corp. · Gastroenterology & Urology
Aug 1982
Decision
22d
Days
Class 2
Risk

K822254 is an FDA 510(k) clearance for the ELECTRIC CORD FOR ENDOSCOPE. This device is classified as a Cord, Electric, For Endoscope (Class II — Special Controls, product code FFZ).

Submitted by Kelleher Corp. (Mchenry, US). The FDA issued a Cleared decision on August 20, 1982, 22 days after receiving the submission on July 29, 1982.

This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number K822254 FDA.gov
FDA Decision Cleared SESE
Date Received July 29, 1982
Decision Date August 20, 1982
Days to Decision 22 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary —

Device Classification

Product Code FFZ — Cord, Electric, For Endoscope
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.1500