Continent Stoma System & Accessories

FDA 510(k) K844186 · Chesebrough-Pond'S U.S.A. Co.

Substantially Equivalent

510(k) numberK844186

Submission

Device name
Continent Stoma System & Accessories
Applicant
Chesebrough-Pond'S U.S.A. Co.
Greenwich, CT, US
Received
October 29, 1984
Decision date
January 15, 1985
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KBG – Trocar, Sinus
Device class
Class I (low risk)
Regulation
21 CFR 874.4420
Specialty
Ear, Nose, Throat

Other 510(k)s with product code KBG

510(k)DeviceApplicantDecision
K033591Reprocessed TrocarsKBG · Traditional Clearmedical, Inc.06/03/2005SE
K013987Reprocessed Disposable TrocarsKBG · Traditional Adven Medical03/01/2002SE

More from Adven Medical

510(k)DeviceDecision
K863866Respiradyne Ii(Tm)BZK · Traditional 01/28/1987SE
K862803Chesebrough Pond's Hydrocolloid DressingFRO · Traditional 11/14/1986SN
K851383Blisterfilm Transparent DressingNAD · Traditional 07/05/1985SN
K851382Chesebrough-Pond's Sequential Wound DressingNAD · Traditional 07/05/1985SN
K851539Chesebrough-Ponds Kangaroo Pump Set W/Easy-Cap CloKNT · Traditional 06/12/1985SE
K843567Kangaroo Nasogastric Feeding TubeKNT · Traditional 02/14/1985SE
K845010Chesebrough-Pond's Uri-Drain Male Urinary PouchEYQ · Traditional 01/15/1985SE
K844789Kangaroo Access II Enteral Feeding ContainerKNT · Traditional 01/02/1985SE
K843128Female Urinary Incontinence SysKNX · Traditional 01/02/1985SE
K843140Isolate Adhesive Bandage for Dry WoundNAD · Traditional 11/08/1984SE

Questions and answers

When was Continent Stoma System & Accessories cleared by the FDA?

Continent Stoma System & Accessories (K844186) received a 510(k) decision of Substantially Equivalent on January 15, 1985, 78 days after the submission was received.

What is the product code of K844186?

The FDA product code is KBG – Trocar, Sinus, a Class I (low risk) device regulated under 21 CFR 874.4420.