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FDA 510(k)

RetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set

K-Number: K160077 · 2016-07-12

ApplicantJbw7 Innovations, LLC
Decision Date2016-07-12
Product CodeLJE
DecisionSubstantially Equivalent

Device Summary

RetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set is a medical device manufactured by Jbw7 Innovations, LLC. It received FDA 510(k) clearance on 2016-07-12 under approval number K160077. The device is classified under product code LJE. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set?

RetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set is a medical device that received FDA 510(k) clearance on 2016-07-12. It is manufactured by Jbw7 Innovations, LLC. The 510(k) number is K160077.

When was RetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set approved by the FDA?

RetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set received FDA 510(k) clearance on 2016-07-12, under approval number K160077.

What company makes RetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set?

RetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set is manufactured by Jbw7 Innovations, LLC.

What is the FDA product code for RetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set?

The FDA product code for RetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set is LJE.

Related Clinical Trials

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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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