Laser Cannister Filter

FDA 510(k) K874615 · Medical Marketing, Inc.

Substantially Equivalent

510(k) numberK874615

Submission

Device name
Laser Cannister Filter
Applicant
Medical Marketing, Inc.
Fischer, TX, US
Received
November 9, 1987
Decision date
June 23, 1988
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HHR – Laser, Surgical, Gynecologic
Device class
Class II (moderate risk)
Regulation
21 CFR 884.4550
Specialty
Obstetrics/Gynecology

Other 510(k)s with product code HHR

510(k)DeviceApplicantDecision
K881507Endocoagulator Model 20 Laser & AccessoriesHHR · Traditional Hgm Medical Laser Systems, Inc.04/27/1989SE
K871875Model 5050 Surgilaser for Ob-Gyn UseHHR · Traditional Lasermatic, Inc.08/22/1988SE
K875314GL-35 Colposcopic Laser SystemHHR · Traditional Laser Engineering, Inc.08/05/1988SE
K880591Laseguide 600A, 600B, 400A, 400B for Ob-Gyn UseHHR · Traditional Laser Peripherals, LLC06/01/1988SE
K880930MDLS 4000,4900,6000,8000,8900 ND:YAG/1700 C02 LaseHHR · Traditional Copper Lasersonics, Inc.05/31/1988SE
K880991Laser Optical Catheter SystemHHR · Traditional Medline Industries, Inc.05/25/1988SE
K880173Model 4900 Nd:Yag Laser for Endometrial AblationHHR · Traditional Cooper Lasersonics, Inc.03/24/1988SE
K874837KTP/532 Laser for Ob-Gyn UseHHR · Traditional Laserscope03/14/1988SE
K875078Heracure LS 500HHR · Traditional W.C. Heraeus GmbH02/22/1988SE
K872709Model 20-C, RL-20A/U, OB-10A/UHHR · Traditional Directed Energy, Inc.02/02/1988SE

More from Directed Energy, Inc.

510(k)DeviceDecision
K874614Suction and Lavage ProbeHET · Traditional 06/23/1988SE
K874612Titanium RodsHET · Traditional 06/23/1988SE
K874611Titanium Backstop with SuctionHET · Traditional 06/23/1988SE

Questions and answers

When was Laser Cannister Filter cleared by the FDA?

Laser Cannister Filter (K874615) received a 510(k) decision of Substantially Equivalent on June 23, 1988, 227 days after the submission was received.

What is the product code of K874615?

The FDA product code is HHR – Laser, Surgical, Gynecologic, a Class II (moderate risk) device regulated under 21 CFR 884.4550.