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FDA 510(k)

BostonSight PD Prosthetic Device

K-Number: K161461 · 2016-07-25

ApplicantBostonsight
Decision Date2016-07-25
Product CodeHQD
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

BostonSight PD Prosthetic Device is a medical device manufactured by Bostonsight. It received FDA 510(k) clearance on 2016-07-25 under approval number K161461. The device is classified under product code HQD. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BostonSight PD Prosthetic Device?

BostonSight PD Prosthetic Device is a medical device that received FDA 510(k) clearance on 2016-07-25. It is manufactured by Bostonsight. The 510(k) number is K161461.

When was BostonSight PD Prosthetic Device approved by the FDA?

BostonSight PD Prosthetic Device received FDA 510(k) clearance on 2016-07-25, under approval number K161461.

What company makes BostonSight PD Prosthetic Device?

BostonSight PD Prosthetic Device is manufactured by Bostonsight.

What is the FDA product code for BostonSight PD Prosthetic Device?

The FDA product code for BostonSight PD Prosthetic Device is HQD.

Related Clinical Trials

NCT07254247 A Unique Body-Powered Terminal Device With Enhanced Grasping Capabilities for Individuals With Upper Limb Loss COMPLETED NCT06899711 External Post-Operative Skull Prosthesis to Prevent Sunken Flap Syndrome in Craniectomy Patients RECRUITING NCT04251377 Single-stage Surgery With Antibiotic-loaded Hydrogel Coated Implants Versus Two Stage Surgery for Secondary Prevention of Complex Chronic Periprosthetic Hip Joint Infection ACTIVE_NOT_RECRUITING NCT04578327 Investigation of Embodiment for Upper Limb Amputees WITHDRAWN NCT06710795 AFFIX: Post-market Study of MaxTack™ Motorized Fixation Device in Subjects Undergoing Ventral Hernia Repair ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 42127028 Proposed standards for prosthetic foot reuse and considerations for donation of used prosthetic feet to low-and middle-income countries. PLOS global public health (2026) PMID: 41929241 A Multidimensional Index Framework for Evaluating the Regulatory Applicability of ISO 10328 Using a Prosthetic Knee Case Study. Medical devices (Auckland, N.Z.) (2026)

Other Devices by Bostonsight

K183175BostonSight Scleral

Related Devices (Code: HQD)

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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.

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