Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long

K-Number: K152771 · 2016-06-17

ApplicantSumitomo Bakelite Co., Ltd.
Decision Date2016-06-17
Product CodeKNS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long is a medical device manufactured by Sumitomo Bakelite Co., Ltd.. It received FDA 510(k) clearance on 2016-06-17 under approval number K152771. The device is classified under product code KNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long?

SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long is a medical device that received FDA 510(k) clearance on 2016-06-17. It is manufactured by Sumitomo Bakelite Co., Ltd.. The 510(k) number is K152771.

When was SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long approved by the FDA?

SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long received FDA 510(k) clearance on 2016-06-17, under approval number K152771.

What company makes SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long?

SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long is manufactured by Sumitomo Bakelite Co., Ltd..

What is the FDA product code for SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long?

The FDA product code for SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long is KNS.

Related Clinical Trials

NCT06940752 VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters ENROLLING_BY_INVITATION NCT07534696 Evaluation of Non-Invasive Pelvic Floor Neuromuscular Stimulation for Urinary Incontinence After Prostatectomy ENROLLING_BY_INVITATION NCT07562113 Pilot Testing of Vagus Nerve Stimulation for Early Spinal Cord Injury Recovery NOT_YET_RECRUITING NCT03078426 Lung MRI in the Management of Idiopathic Pulmonary Fibrosis COMPLETED NCT07595666 Comparison of NeuroEXPLORER PET/CT Versus Standard-of-care PET/CT of the Head and Neck Region. ENROLLING_BY_INVITATION NCT07274527 Amnioinfusion's Protective Effects on Respiratory and Longitudinal Pediatric Outcomes After Intrapartum Thick Meconium Exposure RECRUITING

Other Devices by Sumitomo Bakelite Co., Ltd.

K173004SB Soft Hood - Straight type, SB Soft Hood - Undercut type K182520Flexible Overtube K190621SB Knife/Short type, SB Knife/Standard type, SB Knife/Jr type, SB Knife/Jr type - Long

Related Devices (Code: KNS)

K160417Rezum SystemNxthera, Inc. K160241Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215Olympus Medical Systems Corp. K171158Single Use Electrosurgical knifeOlympus Medical Systems Corp. K171993Zimmon Needle Knife PapillotomeWilson-Cook Medical Inc./Cook Endoscopy K171983Creo Medical Electrosurgical System including Speedboat RS2 Surgical AccessoryCreo Medical, Ltd. K172665Classic Cotton Cannulatome®, CannulaTome II® Double Lumen Sphincterotome, Cotton CannulaTome II® PC, UTS® Ultra Taper Sphincterotome, Tri-Tome pc® Triple Lumen Sphincterotome, Howell D.A.S.H.® Sphincterotome with DomeTip®, Billroth II Sphincterotome, Soehendra® BII Sphincterotome, Models ACU-1 and ACU-1-VL active cordsWilson-Cook Medical Inc./Cook Endoscopy

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑