Endocervical Aspirator

FDA 510(k) K902242 · Innovative Medical Products, Inc.

Substantially Equivalent

510(k) numberK902242

Submission

Device name
Endocervical Aspirator
Applicant
Innovative Medical Products, Inc.
Slidell, LA, US
Received
May 18, 1990
Decision date
October 9, 1990
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HFC – Aspirator, Endocervical
Device class
Class II (moderate risk)
Regulation
21 CFR 884.1050
Specialty
Obstetrics/Gynecology

Other 510(k)s with product code HFC

510(k)DeviceApplicantDecision
K974032Rocket Mucus Sampler Syringe, Sterile, Rocket Mucus Sampler Syringe, Clinically AspiratorHFC · Traditional A & A Medical, Inc.12/22/1997SE
K960263Cervical Mucous Aspiration CatheterHFC · Traditional Cook Urological, Inc.08/29/1996SE
K954903Pedi Vaginal AspiratorHFC · Traditional Cook Urological, Inc.04/29/1996SE
K954102SelectmucusHFC · Traditional Select Medical Systems, Inc.11/21/1995SE
K902032O. B. Pack IVHFC · Traditional Customed, Inc.09/28/1990SE
K902954OBER2 Monitor, Eye Movement (Ophthalmic)HFC · Traditional Permobil AB08/23/1990SE
K895403Aspirette Endocervical AspiratorHFC · Traditional Unimar, Inc.11/29/1989SE
K821134DC Pack TMHFC · Traditional Seamless Hospital Products Co.06/22/1982SE
K812175Endocervical AspiratorHFC · Traditional Fertility Instrumentation, Inc.09/21/1981SE
K801238Accu-Pap T Zone SamplerHFC · Traditional Robert Hasselbrack, M.D.08/12/1980SE

More from Robert Hasselbrack, M.D.

510(k)DeviceDecision
K914538UPH-2000 Universal Oximetry Probe HolderDQA · Traditional 07/14/1992SE

Questions and answers

When was Endocervical Aspirator cleared by the FDA?

Endocervical Aspirator (K902242) received a 510(k) decision of Substantially Equivalent on October 9, 1990, 144 days after the submission was received.

What is the product code of K902242?

The FDA product code is HFC – Aspirator, Endocervical, a Class II (moderate risk) device regulated under 21 CFR 884.1050.