Cleared Traditional

K890371 - INTESTINAL CRUSHING CLAMP
(FDA 510(k) Clearance)

Feb 1989
Decision
11d
Days
Class 1
Risk

K890371 is an FDA 510(k) clearance for the INTESTINAL CRUSHING CLAMP. This device is classified as a Clamp (Class I - General Controls, product code HXD).

Submitted by Kinetic Medical Products (Erie, US). The FDA issued a Cleared decision on February 3, 1989, 11 days after receiving the submission on January 23, 1989.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K890371 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 1989
Decision Date February 03, 1989
Days to Decision 11 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary

Device Classification

Product Code HXD — Clamp
Device Class Class I - General Controls
CFR Regulation 21 CFR 878.4800