Cleared Traditional

IMPACT MODEL 316

K842050 · Impact Instrumentation, Inc. · General & Plastic Surgery
Aug 1984
Decision
73d
Days
Class 2
Risk

About This 510(k) Submission

K842050 is an FDA 510(k) clearance for the IMPACT MODEL 316, a Apparatus, Suction, Ward Use, Portable, Ac-powered (Class II — Special Controls, product code JCX), submitted by Impact Instrumentation, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 3, 1984, 73 days after receiving the submission on May 22, 1984. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4780.

Submission Details

510(k) Number K842050 FDA.gov
FDA Decision Cleared SESE
Date Received May 22, 1984
Decision Date August 03, 1984
Days to Decision 73 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code JCX — Apparatus, Suction, Ward Use, Portable, Ac-powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4780

Similar Devices — JCX Apparatus, Suction, Ward Use, Portable, Ac-powered

All 75
MV Flow Aspiration Pump (MVFLOWPMP01)
K243638 · Microvention · Jun 2025
Cary
K251111 · Excitus AS · May 2025
Riptide? Aspiration Pump; Riptide? Collection Canister with Intermediate Tubing
K243418 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · Dec 2024
Easycess Aspiration Pump
K233428 · Guangzhou Easycess Medical Co.,Ltd · Nov 2023
120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2 Specimen Collection Manifold Kit (0750-200-000);V2 Specimen Collection Tray (0750-210-000)
K222552 · Stryker Instruments · Dec 2022
Acare Suction Unit
K182950 · Acare Technology Co., Ltd. · Aug 2019