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FDA 510(k)

ORISE Tissue Retractor System

K-Number: K173400 · 2018-02-09

ApplicantBoston Scientific
Decision Date2018-02-09
Product CodeFED
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ORISE Tissue Retractor System is a medical device manufactured by Boston Scientific. It received FDA 510(k) clearance on 2018-02-09 under approval number K173400. The device is classified under product code FED. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORISE Tissue Retractor System?

ORISE Tissue Retractor System is a medical device that received FDA 510(k) clearance on 2018-02-09. It is manufactured by Boston Scientific. The 510(k) number is K173400.

When was ORISE Tissue Retractor System approved by the FDA?

ORISE Tissue Retractor System received FDA 510(k) clearance on 2018-02-09, under approval number K173400.

What company makes ORISE Tissue Retractor System?

ORISE Tissue Retractor System is manufactured by Boston Scientific.

What is the FDA product code for ORISE Tissue Retractor System?

The FDA product code for ORISE Tissue Retractor System is FED.

Related Clinical Trials

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Related PubMed Literature

PMID: 42168293 Comparative in vitro and in vivo assessment of three experimental extracellular matrix meshes for soft tissue remodeling. Scientific reports (2026) PMID: 40942702 Digital Cardiovascular Twins, AI Agents, and Sensor Data: A Narrative Review from System Architecture to Proactive Heart Health. Sensors (Basel, Switzerland) (2025)

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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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