510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
NQUClass II

Dislodger, Stone, Basket, Ureteral, Metal, Reprocessed

21 CFR 876.4680 / Gastroenterology, Urology
FDA source (opens on fda.gov)

NQU is the FDA product code for Dislodger, Stone, Basket, Ureteral, Metal, Reprocessed, a class II device type, regulated under 21 CFR 876.4680. FDA's definition for this code reads: "A ureteral stone dislodger is a device that consists of a bougie or a catheter with an expandable wire basket near the tip. It is inserted through a cystoscope and used to entrap and remove stones from the ureter. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911...". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
NQU
Device name
Dislodger, Stone, Basket, Ureteral, Metal, Reprocessed
FDA definition
A ureteral stone dislodger is a device that consists of a bougie or a catheter with an expandable wire basket near the tip. It is inserted through a cystoscope and used to entrap and remove stones from the ureter. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
Regulation
21 CFR 876.4680
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code NQU.