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FDA 510(k)

Smith & Nephew TRUCLEAR ULTRA Mini Tissue Removal Device

K-Number: K161763 · 2016-11-22

ApplicantSmith & Nephew, Inc.
Decision Date2016-11-22
Product CodeHIH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Smith & Nephew TRUCLEAR ULTRA Mini Tissue Removal Device is a medical device manufactured by Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2016-11-22 under approval number K161763. The device is classified under product code HIH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Smith & Nephew TRUCLEAR ULTRA Mini Tissue Removal Device?

Smith & Nephew TRUCLEAR ULTRA Mini Tissue Removal Device is a medical device that received FDA 510(k) clearance on 2016-11-22. It is manufactured by Smith & Nephew, Inc.. The 510(k) number is K161763.

When was Smith & Nephew TRUCLEAR ULTRA Mini Tissue Removal Device approved by the FDA?

Smith & Nephew TRUCLEAR ULTRA Mini Tissue Removal Device received FDA 510(k) clearance on 2016-11-22, under approval number K161763.

What company makes Smith & Nephew TRUCLEAR ULTRA Mini Tissue Removal Device?

Smith & Nephew TRUCLEAR ULTRA Mini Tissue Removal Device is manufactured by Smith & Nephew, Inc..

What is the FDA product code for Smith & Nephew TRUCLEAR ULTRA Mini Tissue Removal Device?

The FDA product code for Smith & Nephew TRUCLEAR ULTRA Mini Tissue Removal Device is HIH.

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Related PubMed Literature

PMID: 41516911 Substance-Based Medical Device in Wound Care: Bridging Regulatory Clarity and Therapeutic Innovation. Polymers (2025) PMID: 41273038 Optimization of the Nonclinical Biological Evaluation of Medical Devices Using Toxicologic Pathology Best Practices. Advanced healthcare materials (2026) PMID: 41269675 Pathology as a Core Discipline in the Biological Evaluation of Medical Devices. International journal of toxicology (2026) PMID: 41040861 Enhancing post-operative hypothyroidism treatment: rat thyroid autotransplantation into a pre-vascularized, retrievable cell pouch™ device. Frontiers in endocrinology (2025)

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Related Devices (Code: HIH)

K160751Symphion Endoscope and Symphion Cervical SheathBoston Scientific K160510MAKO 7Nvision Medical Corporation K172566Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal DevicesHologic, Inc. K170660Endosee Hysteroscope with Disposable Diagnostic (Dx) CannulaCooperSurgical, Inc. K182006Omni Hysteroscope, Omni Hysteroscope Kits, Omni SheathsHologic, Inc. K180496TruClear Elite HysteroscopeCovidien

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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