Endo-Sponge

FDA 510(k) K892218 · Endovations

Substantially Equivalent

510(k) numberK892218

Submission

Device name
Endo-Sponge
Applicant
Endovations
Mechanicsburg, PA, US
Received
April 3, 1989
Decision date
May 31, 1989
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
MNL – Accessories, Cleaning Brushes, For Endoscope
Device class
Class I (low risk)
Regulation
21 CFR 876.1500
Specialty
Gastroenterology, Urology

Other 510(k)s with product code MNL

510(k)DeviceApplicantDecision
K950689UcbMNL · Traditional Cox Medical Ent., Inc.03/06/1995SE
K946293Mill-Rose Scope Cleaning BrushMNL · Traditional Mill-Rose Laboratory02/16/1995SE
K874239Cleaning BrushMNL · Traditional Endovations12/29/1987SE

More from Endovations

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K934315Endovations(R) .035 Pre-Cut PapillatomeKNS · Traditional 02/28/1994SE
K9138412 Lumen Endos Retro Cholangiopancrea Injec CathFGE · Traditional 10/08/1991SE
K9138705MM MicroscissorsGCJ · Traditional 09/16/1991SE
K911155Oval Cup Biopsy ForcepFCF · Traditional 08/07/1991SE
K883093Transendoscopic Aspiration NeedleFBK · Traditional 12/08/1988SE
K873360Enteron Percutan. Endoscopic Gastrostomy Tray-PegKNT · Traditional 03/30/1988SE
K875264Washing CatheterOCX · Traditional 03/29/1988SE

Questions and answers

When was Endo-Sponge cleared by the FDA?

Endo-Sponge (K892218) received a 510(k) decision of Substantially Equivalent on May 31, 1989, 58 days after the submission was received.

What is the product code of K892218?

The FDA product code is MNL – Accessories, Cleaning Brushes, For Endoscope, a Class I (low risk) device regulated under 21 CFR 876.1500.