510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NAMClass II

Stimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence

21 CFR 876.5310 / Gastroenterology, Urology
FDA source (opens on fda.gov)

NAM is the FDA product code for Stimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence, a class II device type, regulated under 21 CFR 876.5310. As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
NAM
Device name
Stimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence
Regulation
21 CFR 876.5310
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
No
Ingested clearances
8
Ingested recalls
0

Clearances, product code NAM

By decision year
8 clearances under product code NAM with a decision year between 2000 and 2023, 2000 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NAM by decision year
YearClearances
20001
20051
20061
20071
20101
20131
20211
20231

Applicants with the most clearances

Product code NAM
Applicants holding the most 510(k) clearances under product code NAM
ApplicantClearances
Uroplasty, LLC4
Advanced Uro-Solutions, Inc.1
Avation Medical1
Exodus Innovations1
Urosurge, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code