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

Anchor, Fascial

21 CFR 878.4300 / General, Plastic Surgery
FDA source (opens on fda.gov)

NEH is the FDA product code for Anchor, Fascial, a class II device type, regulated under 21 CFR 878.4300. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
NEH
Device name
Anchor, Fascial
Regulation
21 CFR 878.4300
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code NEH

By decision year
1 clearance under product code NEH with a decision year between 2001 and 2001, 2001 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NEH by decision year
YearClearances
20011

Applicants with the most clearances

Product code NEH
Applicants holding the most 510(k) clearances under product code NEH
ApplicantClearances
American Medical Systems, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

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