FDA 510(k)

Acquire S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device

K-Number: K223616 · 2022-12-30

Decision Date2022-12-30

Product CodeODG

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Acquire S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2022-12-30 under approval number K223616. The device is classified under product code ODG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Acquire S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device?

Acquire S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device is a medical device that received FDA 510(k) clearance on 2022-12-30. It is manufactured by Boston Scientific Corporation. The 510(k) number is K223616.

When was Acquire S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device approved by the FDA?

Acquire S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device received FDA 510(k) clearance on 2022-12-30, under approval number K223616.

What company makes Acquire S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device?

Acquire S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device is manufactured by Boston Scientific Corporation.

What is the FDA product code for Acquire S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device?

The FDA product code for Acquire S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device is ODG.

Related Clinical Trials

NCT06940752 VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters ENROLLING_BY_INVITATION NCT07548151 Guided Needle Insertion for Vascular Access COMPLETED NCT07099092 Causal Mechanisms of Odor-Guided Behavior in Humans NOT_YET_RECRUITING NCT07615972 Efficacy of a Roller Device Facilitating Self-massage in the Treatment of Chronic Lateral Epicondylitis NOT_YET_RECRUITING NCT02193425 Reliability of the Human Brain Connectome COMPLETED NCT07612644 Hemorrhage Elimination During Lumbar Puncture Using Ultrasound Measurements (HELPUS) RECRUITING

Related PubMed Literature

PMID: 41477286 Comparison of the Safety and Efficacy of Biodegradable Microneedle Acupuncture and Sterile Acupuncture: study protocol for a prospective, confirmatory, superiority, multicenter, parallel, single-blinded randomized controlled trial. Journal of pharmacopuncture (2025)

Other Devices by Boston Scientific Corporation

K163200Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Cathete K163174Emerge PTCA Dilatation Catheter K162350Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Express SD Biliary Monorail Premounted Stent System, Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Catheter, Sterling Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Ultra-Soft SV Monorail Balloon Dilatation Catheter 0.018 K162404Express SD Biliary Monorail Premounted Stent System K160823NC Quantum Apex PTCA Dilatation Catheter K160514OptiCross 18, 30 MHz Peripheral Imaging Catheter

View all 176 devices →

Related Devices (Code: ODG)

K160845Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) DeviceBoston Scientific Corporation K173184Expect Slimline (SL) Endoscopic Ultrasound Aspiration NeedleBoston Scientific K172309Endoscopic Ultrasound Aspiration NeedleMicro-Tech (Nanjing) Co., Ltd. K162447PENTAX Medical Endoscopic Ultrasound System, EG-3270UK Upper G.I. Video Scope (Convex Array Type) with EPK-i5010 Video Processor and HI VISION Preirus Ultrasound ScannerPentax of America, Inc. K163058Expect Slimline (SL) Endoscopic Ultrasound Aspiration NeedleBoston Scientific K182004PENTAX Medical Endoscopic Ultrasound SystemPentax of America, Inc.

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.