Laminaria 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MM

FDA 510(k) K021012 · Quality Medical Solusions, LLC

Substantially Equivalent

510(k) numberK021012

Submission

Device name
Laminaria 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MM
Applicant
Quality Medical Solusions, LLC
Alpharetta, GA, US
Received
March 29, 2002
Decision date
June 25, 2002
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HDY – Dilator, Cervical, Hygroscopic-Laminaria
Device class
Class II (moderate risk)
Regulation
21 CFR 884.4260
Specialty
Obstetrics/Gynecology

Other 510(k)s with product code HDY

510(k)DeviceApplicantDecision
K040625Atad Ard CatheterHDY · Traditional Atad Developments , Ltd.01/18/2005SE
K011512Mmodification to LaminariaHDY · Traditional A & A Medical, Inc.07/09/2001SE
K955072LaminariaHDY · Traditional Cti Corp., Ltd.05/22/1996SE
K892220Laminaria TentHDY · Traditional Berkeley Medevices06/14/1989SE
K881295Laminaria CurexHDY · Traditional Harold W. Berger Co.08/10/1988SE
K881312LaminariaHDY · Traditional Busse Hospital Disposables, Inc.05/23/1988SE
K880196LaminariaHDY · Traditional Medgyn Products, Inc.05/06/1988SE
K845006Sun Medical Laminaria Cervical DilatorHDY · Traditional Sun Medical, Inc.05/01/1985SE
K833068Laminaria Japonica Cervical DilatorHDY · Traditional Medi-Spec02/04/1984SE
K782067Dilator, Mizutani Laminaria TentHDY · Traditional British Marketing Ent., Ltd.01/03/1979SE

Questions and answers

When was Laminaria 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MM cleared by the FDA?

Laminaria 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MM (K021012) received a 510(k) decision of Substantially Equivalent on June 25, 2002, 88 days after the submission was received.

What is the product code of K021012?

The FDA product code is HDY – Dilator, Cervical, Hygroscopic-Laminaria, a Class II (moderate risk) device regulated under 21 CFR 884.4260.