Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Jbw7 Innovations, LLC. It received FDA 510(k) clearance on 2016-07-12 under 510(k) 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. The listed applicant is Jbw7 Innovations, LLC. The 510(k) number is K160077.

When did RetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set receive FDA 510(k) clearance?

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

Who is the listed applicant for RetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set?

The FDA 510(k) record lists Jbw7 Innovations, LLC as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT02290769Time of Cannulation During Primary ERCP With Short Guide Wire Rapid Exchange or With Long Guide WireSUSPENDEDNCT06958731In-plane Versus Real Time Bi-plane Single-operator Laser-assisted With a Innovative T-shaped Probe for Ultrasound-guided Internal Jugular Vein Catheterization:A Randomized Controlled TrialENROLLING_BY_INVITATIONNCT07678255Access Sheaths With Aspiration for Renal RetrOgrade Surgery, Randomized CompArative OutcomesNOT_YET_RECRUITING

Related Devices (Code: LJE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250448Disposable Percutaneous Nephrostomy Dilatation KitShenzhen Trious Medical Technology Co., Ltd.K222705Introducer NeedleYoucare Technology Co.,Ltd. (Wuhan)K211911Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture SetsColoplast Corp.K201165In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz SheathColoplast Corp.K191498Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-LocCook IncorporatedK190903Lawson Retrograde Nephrostomy Wire Puncture SetCook Incorporated

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.

↑