510(k) clearances

Lipipor NLF1A Infusion Filter, Lipipor NLF2A & NLF2NTA Infusion Filters, Lipipor TNA2A Infusion Filter

Global Life Sciences Solutions USA, LLC · General Hospital

K261403Substantially EquivalentTraditionalFPB
Open FDA's page for this record
Third party flag
N
City
Marlborough
Advisory committee description
General Hospital
Address 1
100 Results Way
Statement or summary
Summary
Product code
FPB
Zip code
01752
Applicant
Global Life Sciences Solutions USA, LLC
Decision date
2026-08-31
Decision code
SESE
Country code
US
Device name
Lipipor NLF1A Infusion Filter, Lipipor NLF2A & NLF2NTA Infusion Filters, Lipipor TNA2A Infusion Filter
Advisory committee
HO
Contact
Brian Goetz
K number
K261403
State
MA
Date received
2026-04-29
Review advisory committee
HO
Postal code
01752
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Filter, Infusion Line
Medical specialty description
General Hospital
Regulation number
880.5440
Device class
2
Registration number
9616567, 3022555290, 3012821221, 3003704957, 3033536319, 3005941719, 1423507, 3016904853, 9612052, 8020892, 2528981, 3010173425, 3002807257, 1223004, 2029275, 9612003, 3002807314, 3013557562, 3012354669, 1220477, 3004569180, 1422078, 2245270, 3013517171, 3008132398, 1526534, 3006425876, 1416980, 1718873, 3015422213, 1057358, 9680602, 3009328501, 1061124, 1530671, 3012494290, 3002907620, 2650143, 3011088743, 3002807315 +11 more
FEI number
3002807036, 3022555290, 1000306431, 3012821221, 3003704957, 3033536319, 3016904853, 2528981, 3002807257, 2648209, 3013557562, 3002807314, 3002806443, 3012354669, 1220477, 3004569180, 1000208608, 2245270, 3001639729, 3013517171, 1000120555, 3002807666, 1526534, 3006425876, 1416980, 1718873, 3015422213, 3002807091, 3009328501, 3012494290, 1000036860, 3002907620, 1000268645, 3011088743, 3008002452, 3002807315, 3015276780, 3002807111, 3003595336, 3043226252 +11 more
Wholesale access for licensed clinicians.

Free to join: your NPI is checked against the federal registry at signup, then wholesale pricing and the professional shelves open.

Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.