Data / Medical devices / United States / Retroperc, Inc.
Retroperc, Inc.: FDA-registered device maker in Jersey City, NJ, United States, 1 510(k) clearance
Retroperc, Inc. is registered with the FDA (registration 3019946783) in Jersey City, NJ, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated July 12, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3019946783
- Address
- 111 Town Square Pl Ste 1203, Jersey City, NJ, United States, 07310
- Owner or operator
- RetroPerc, Inc. (10082484)
- Roles
- Specification developer
- First device listed
- August 3, 2021
- Registered through
- 2026
- Brand names listed
- RetroPerc
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Nephrostomy | LJE | U | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 12, 2016 | K160077 | RetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set | LJE | Substantially Equivalent | Jbw7 Innovations, LLC | accessdata.fda.gov |
Compare with other makers
Updated July 12, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.