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

Paper, Obstetric Ph

21 CFR 862.1550 / Clinical Chemistry
FDA source (opens on fda.gov)

LNW is the FDA product code for Paper, Obstetric Ph, a class I device type, regulated under 21 CFR 862.1550. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
LNW
Device name
Paper, Obstetric Ph
Regulation
21 CFR 862.1550
Device class
Class I
Review panel
Clinical Chemistry
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
4
Ingested recalls
2

Clearances, product code LNW

By decision year
4 clearances under product code LNW with a decision year between 1985 and 2003, 1985 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code LNW by decision year
YearClearances
19851
19961
20011
20031

Applicants with the most clearances

Product code LNW
Applicants holding the most 510(k) clearances under product code LNW
ApplicantClearances
Femtek,Llc.3
Uro Pharmaceuticals, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 31 companies shown, in name order