FDA 510(k)

Intra-Operative Positioning System (IOPS®)

K-Number: K243842 · 2025-03-06

Decision Date2025-03-06

Product CodeDQK

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Intra-Operative Positioning System (IOPS®) is a medical device manufactured by Centerline Biomedical, Inc.. It received FDA 510(k) clearance on 2025-03-06 under approval number K243842. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Intra-Operative Positioning System (IOPS®)?

Intra-Operative Positioning System (IOPS®) is a medical device that received FDA 510(k) clearance on 2025-03-06. It is manufactured by Centerline Biomedical, Inc.. The 510(k) number is K243842.

When was Intra-Operative Positioning System (IOPS®) approved by the FDA?

Intra-Operative Positioning System (IOPS®) received FDA 510(k) clearance on 2025-03-06, under approval number K243842.

What company makes Intra-Operative Positioning System (IOPS®)?

Intra-Operative Positioning System (IOPS®) is manufactured by Centerline Biomedical, Inc..

What is the FDA product code for Intra-Operative Positioning System (IOPS®)?

The FDA product code for Intra-Operative Positioning System (IOPS®) is DQK.

Related Clinical Trials

NCT07191067 Pivotal Study on the NOVABLOC System for Patients Undergoing Primary Total Knee Arthroplasty RECRUITING NCT06011187 Assisted Fluid Management (AFM) System and Postoperative Outcome After High-risk Abdominal Surgery COMPLETED NCT03280862 DANISH-CRT - Does Electric Targeted LV Lead Positioning Improve Outcome in Patients With Heart Failure and Prolonged QRS COMPLETED NCT07613892 Post Operative Skin Approximation With Cyanoacrylate Based Wound Closure Adhesives COMPLETED NCT07614581 Intra-Sessional Autonomic Arc Detection in Ketamine-Assisted Therapy for PTSD: A Signal Characterisation Pilot Study NOT_YET_RECRUITING NCT06904651 VADIOR: Advantages of Pre-operative Positioning of Peripherally Inserted Vascular Accesses in DIVA Patients Undergoing Orthopedic Surgery ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 41166829 Assessment of intra-operative impact durability of additively manufactured mock lumbar intervertebral body fusion devices. Journal of biomechanics (2026)

Other Devices by Centerline Biomedical, Inc.

K190106Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire ; Tracking Pad ; Guidewire Handle K230309Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1) and IOPS Reverse Curve Catheter (RCC-1); IOPS Guidewire (ATW-2); IOPS Tracking Pad (TP-1); IOPS Guidewire Handle (SSH-1) K242133Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System (IOPS®) (Guidewire Handle) K241243Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning System (IOPS®) Viewpoint (Double Curve Catheters) K254089IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS Viewpoint Simple Curve Catheter, 125cm (C01251); IOPS Viewpoint Double Curve Catheter, 75cm (C00752); IOPS Viewpoint Double Curve Catheter, 125cm (C02152); IOPS Guidewire 2 (ATW-2); IOPS Fiducial Tracking Pad (T02111); IOPS Guidewire Handle (H01035)

Related Devices (Code: DQK)

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Official Source

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