Suction Tubes

FDA 510(k) K822724 · Exco, Inc.

Substantially Equivalent

510(k) numberK822724

Submission

Device name
Suction Tubes
Applicant
Exco, Inc.
Mchenry, IL, US
Received
September 7, 1982
Decision date
October 13, 1982
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
BSY – Catheters, Suction, Tracheobronchial
Device class
Class I (low risk)
Regulation
21 CFR 868.6810
Specialty
Anesthesiology

Other 510(k)s with product code BSY

510(k)DeviceApplicantDecision
K031997Mallinckrodt Dar Ty-Care / Ty-Care Exel Closed Suction SystemBSY · Traditional Mallinckrodt Dar S.R.L.11/25/2003SE
K992902Ambu Hand Power Suction PumpBSY · Traditional Ambu, Inc.10/25/1999SE
K982945Dual Purpose Closed CatheterBSY · Traditional Spirit Medical Systems, Inc.09/22/1998SE
K981910Suction CatheterBSY · Traditional Ni-Med, Inc.08/24/1998SE
K972258Hi-Care Closed Suction SystemBSY · Traditional Mallinckrodt Medical12/29/1997SE
K973199Amsino Suction CatheterBSY · Traditional Amsino Intl., Inc.09/10/1997SE
K961707Trach-Eze Closed Ventilation Suction SystemBSY · Traditional Sorenson Critical Care03/11/1997SE
K964369Trach Care Set with MicrobanBSY · Traditional Ballard Medical Products02/11/1997SE
K960488Neo 2 Line Suction SystemBSY · Traditional Alcove Medical, Inc.04/26/1996SE
K955831Argyle Aspr-Care Closed Suction SystemBSY · Traditional Sherwood Medical Co.03/28/1996SE

More from Sherwood Medical Co.

510(k)DeviceDecision
K844203Enternal Feeding Tube SILICONE-EF401, 402 & 403KNT · Traditional 01/02/1985SE
K844175Enternal Feeding Tube-Polyurethane EF504KNT · Traditional 01/02/1985SE
K844174Flexible Stainless Steel Stylet for Enternal FeediKNT · Traditional 12/07/1984SE
K832628Vygon Thoracic Drainage-Various #'SKDD · Traditional 01/30/1984SE
K831802Life Vac #2191 & 2192LJS · Traditional 01/11/1984SE
K833079Centracath #130,135 & 137-HEMOCATH #FOZ · Traditional 12/29/1983SE
K830910Manometer Set C.V.P. #S 298/299KRK · Traditional 04/05/1983SE
K822879Enteral Nutrition 1KNT · Traditional 11/16/1982SE
K822836Microflex-VenofluxFPA · Traditional 10/15/1982SE
K822691Vygon Epidural Anaesthesia TrayCAZ · Traditional 10/15/1982SE

Questions and answers

When was Suction Tubes cleared by the FDA?

Suction Tubes (K822724) received a 510(k) decision of Substantially Equivalent on October 13, 1982, 36 days after the submission was received.

What is the product code of K822724?

The FDA product code is BSY – Catheters, Suction, Tracheobronchial, a Class I (low risk) device regulated under 21 CFR 868.6810.