Atlas FDA

RetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set

FDA 510(k) clearance K160077 · decided 2016-07-12

Clearance details

K-number
K160077
Device name
RetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set
Applicant
Jbw7 Innovations, LLC
Decision
Substantially Equivalent
Date received
2016-01-14
Decision date
2016-07-12
Days to decision
180 days
Clearance type
Traditional
Product code
LJE
Device class
U
Medical specialty
Unknown
Advisory committee
Unknown
Location
Southfield, MI, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.