LS3000 Cannula Uterine Suction

FDA 510(k) K862476 · Engineering, Inc.

Substantially Equivalent

510(k) numberK862476

Submission

Device name
LS3000 Cannula Uterine Suction
Applicant
Engineering, Inc.
Foster City, CA, US
Received
June 30, 1986
Decision date
July 18, 1986
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HHI – System, Abortion, Vacuum
Device class
Class II (moderate risk)
Regulation
21 CFR 884.5070
Specialty
Obstetrics/Gynecology

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K983181CytoprepHHI · Traditional Cytoprep Inc. Est.11/16/1998SE
K931205Medi Vac Specimen Collector and TransporterHHI · Traditional Baxter Healthcare Corp03/15/1994SE
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K900641Cannula, Suction UterineHHI · Traditional Williams Specialty Products, Inc.03/30/1990SE
K900642Swivel AdapterHHI · Traditional Williams Specialty Products, Inc.03/19/1990SE
K880734Scented or Scented Deodorized Menstrual PadsHHI · Traditional Personal Products Co.04/25/1988SE
K873552Cannula and General Purpose AspiratorHHI · Traditional Cosmedtech, Inc.11/25/1987SE
K870574Cosmedtech General AspiratorHHI · Traditional Cosmedtech, Inc.03/05/1987SE

More from Cosmedtech, Inc.

510(k)DeviceDecision
K881521Modified Servo SyringeDXT · Traditional 05/31/1988SE
K862749LS9000 Suction Biopsy NeedleGDM · Traditional 09/15/1986SE
K854359LM2000A Surgical Suction MonitorKDQ · Traditional 03/03/1986SE
K854844LS1000 Surgical Aspirator IIBTA · Traditional 02/12/1986SN

Questions and answers

When was LS3000 Cannula Uterine Suction cleared by the FDA?

LS3000 Cannula Uterine Suction (K862476) received a 510(k) decision of Substantially Equivalent on July 18, 1986, 18 days after the submission was received.

What is the product code of K862476?

The FDA product code is HHI – System, Abortion, Vacuum, a Class II (moderate risk) device regulated under 21 CFR 884.5070.