Kittner Dissector/Peanut/Cherry/Stick/Triangle Sponge/Gauze Rosebud

Q: What is the product code of K940904?

The FDA product code is EFQ – Gauze/Sponge, Internal, a Unclassified device.

FDA 510(k) K940904 · Medical Insights, Inc.

Substantially Equivalent

510(k) numberK940904

Submission

Device name: Kittner Dissector/Peanut/Cherry/Stick/Triangle Sponge/Gauze Rosebud
Applicant: Medical Insights, Inc.
Mystic, CT, US
Received: February 24, 1994
Decision date: April 14, 1994
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code: EFQ – Gauze/Sponge, Internal
Device class: Unclassified

Other 510(k)s with product code EFQ

510(k)	Device	Applicant	Decision
K991757	Non-Absorbable Gauze for External Use, Sterile and Non SterileEFQ · Traditional	Furlong Industries	08/12/1999SE
K991215	Symtex Gauze Pads (1'S) and Symtex Gauze Sponges Sterile 2'S and Sterile 10'SEFQ · Traditional	Symtex Healthcare Corp.	06/11/1999SE
K990974	Vitop DressingEFQ · Traditional	Wonder & Bioenergy Hi-Tech America, Inc.	06/09/1999SE
K990584	Gauze Sponges: Laparotomy Sponge, X-Ray DetectableEFQ · Traditional	Broadline Medical Industries	04/23/1999SE
K984187	Crosstex Non-Woven SpongesEFQ · Traditional	Crosstex Intl.	02/18/1999SE
K983016	Gauze, Sponges, Cat # 11-003EFQ · Traditional	Vitalcare Group, Inc.	02/12/1999SE
K983348	Dynarex Tracheostomy SpongeEFQ · Traditional	Dynarex Corp.	12/11/1998SE
K983450	Starryshine Gauze SpongeEFQ · Traditional	T.C. Dental Products, Inc.	11/12/1998SE
K982648	Joan IIEFQ · Traditional	Celanese Acetate Co.	09/30/1998SE
K980791	Dumex Pak-Its Woven Ribbon PackingEFQ · Traditional	Dumex Medical Surgical Products, Ltd.	04/29/1998SE

More from Dumex Medical Surgical Products, Ltd.

510(k)	Device	Decision
K940903	Tonsil Sponge, Gauze Dissector, Cylindrical SpongesKBM · Traditional	04/14/1994SE
K940901	Non-Woven SpongeEFQ · Traditional	03/31/1994SE
K924958	Biopsy/Myelo/Arthro/Amniocent/Basic Skin Prep TrayKDD · Traditional	06/07/1993SEKD

Questions and answers

When was Kittner Dissector/Peanut/Cherry/Stick/Triangle Sponge/Gauze Rosebud cleared by the FDA?

Kittner Dissector/Peanut/Cherry/Stick/Triangle Sponge/Gauze Rosebud (K940904) received a 510(k) decision of Substantially Equivalent on April 14, 1994, 49 days after the submission was received.

What is the product code of K940904?

The FDA product code is EFQ – Gauze/Sponge, Internal, a Unclassified device.