Phoenix

FDA 510(k) K895855 · Medical and Scientific Enterprises, Inc.

Substantially Equivalent

510(k) numberK895855

Submission

Device name
Phoenix
Applicant
Medical and Scientific Enterprises, Inc.
Foxboro, MA, US
Received
October 2, 1989
Decision date
January 22, 1990
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KNS – Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Device class
Class II (moderate risk)
Regulation
21 CFR 876.4300
Specialty
Gastroenterology, Urology

Other 510(k)s with product code KNS

510(k)DeviceApplicantDecision
K262460Rezum SystemKNS · Traditional Boston Scientific09/03/2026SE
K260962SphincterotomeKNS · Traditional Taewoong Medical Co., Ltd.05/21/2026SE
K252388Vanquish Water Vapor Ablation DeviceKNS · Traditional Francis Medical, Inc.11/26/2025SE
K252889Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)KNS · Traditional Olympus Medical Systems Corporation11/25/2025SE
K250945Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use…KNS · Traditional Olympus Medical Systems Corp.10/17/2025SE
K250351Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife…KNS · Traditional Olympus Medical Systems Corporation10/10/2025SE
K251104SureTome™ SW Sphincterotome with DomeTipKNS · Traditional Wilson-Cook Medical09/29/2025SE
K251226Aqua Medical RF Vapor Ablation SystemKNS · Traditional Aqua Medical, Inc.08/08/2025SE
K250584Rezum SystemKNS · Traditional Boston Scientific Corporation06/11/2025SE
K242774SpydrBlade Flex Instrument (PRD-RG1-001)KNS · Traditional Creo Medical, Ltd.06/06/2025SE

More from Creo Medical, Ltd.

510(k)DeviceDecision
K933131Bistat 70/70-I Electrosurgical UnitGEI · Traditional 02/15/1994SE
K913881Endostat Electrosurgical UnitKNS · Traditional 11/01/1991SE
K882453Polyscan Digital ScannerIYW · Traditional 11/23/1988SE
K861233Dual Photon Bone DensitometerKGI · Traditional 03/03/1987SE

Questions and answers

When was Phoenix cleared by the FDA?

Phoenix (K895855) received a 510(k) decision of Substantially Equivalent on January 22, 1990, 112 days after the submission was received.

What is the product code of K895855?

The FDA product code is KNS – Unit, Electrosurgical, Endoscopic (With Or Without Accessories), a Class II (moderate risk) device regulated under 21 CFR 876.4300.