Cleared Traditional

K782046 - C-CORD
(FDA 510(k) Clearance)

K782046 · Concept, Inc. · Gastroenterology & Urology
Jan 1979
Decision
33d
Days
Class 2
Risk

K782046 is an FDA 510(k) clearance for the C-CORD. This device is classified as a Cord, Electric, For Endoscope (Class II — Special Controls, product code FFZ).

Submitted by Concept, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 10, 1979, 33 days after receiving the submission on December 8, 1978.

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

Submission Details

510(k) Number K782046 FDA.gov
FDA Decision Cleared SESE
Date Received December 08, 1978
Decision Date January 10, 1979
Days to Decision 33 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