Cleared Traditional

K863146 - BOWEN SUTURE PASSER
(FDA 510(k) Clearance)

K863146 · Bowen & Company, Inc. · Orthopedic
Sep 1986
Decision
21d
Days
Class 1
Risk

K863146 is an FDA 510(k) clearance for the BOWEN SUTURE PASSER. This device is classified as a Passer, Wire, Orthopedic (Class I — General Controls, product code HXI).

Submitted by Bowen & Company, Inc. (Rockville, US). The FDA issued a Cleared decision on September 5, 1986, 21 days after receiving the submission on August 15, 1986.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.4540.

Submission Details

510(k) Number K863146 FDA.gov
FDA Decision Cleared SESE
Date Received August 15, 1986
Decision Date September 05, 1986
Days to Decision 21 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary —

Device Classification

Product Code HXI — Passer, Wire, Orthopedic
Device Class Class I — General Controls
CFR Regulation 21 CFR 888.4540