Perforated Soaking Tube

FDA 510(k) K874596 · Specialty Medical Products Co.

Substantially Equivalent

510(k) numberK874596

Submission

Device name
Perforated Soaking Tube
Applicant
Specialty Medical Products Co.
Bountiful, UT, US
Received
November 9, 1987
Decision date
December 2, 1987
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
GBQ – Catheter, Continuous Irrigation
Device class
Class I (low risk)
Regulation
21 CFR 878.4200
Specialty
General, Plastic Surgery

Other 510(k)s with product code GBQ

510(k)DeviceApplicantDecision
K941356Microflow Irrigation SystemGBQ · Traditional Jedmed Instrument Co.05/19/1994SE
K921464CAT.#40100, 40102, 40104 & 40106 Yankauer Suct IntGBQ · Traditional Trinity Laboratories, Inc.05/05/1992SE
K882647Gesco Catheterization TrayGBQ · Traditional Gesco Intl., Inc.09/09/1988SESD
K873097Procedual Changes/Assembly Process for Plus PaksGBQ · Traditional Ipax, Inc.09/04/1987SE
K872787Modified CurlcathGBQ · Traditional Quinton, Inc.08/04/1987SE
K791400Gastric Lavage Kit-DisposableGBQ · Traditional Acumed Instruments Corp.08/16/1979SE
K771732Thornton Anterior Chamber IrrigatorGBQ · Traditional Concept, Inc.09/28/1977SE

More from Concept, Inc.

510(k)DeviceDecision
K924707Various Anesthetic Kits or TraysCAZ · Traditional 06/17/1993SEKD
K922533IV Start Kit Custom SMP # A-ZLRS · Traditional 03/23/1993SEKD
K922845Basic Dressing Change Tray SMP 102AFRG · Traditional 12/29/1992SEKD

Questions and answers

When was Perforated Soaking Tube cleared by the FDA?

Perforated Soaking Tube (K874596) received a 510(k) decision of Substantially Equivalent on December 2, 1987, 23 days after the submission was received.

What is the product code of K874596?

The FDA product code is GBQ – Catheter, Continuous Irrigation, a Class I (low risk) device regulated under 21 CFR 878.4200.