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Life Science Outsourcing: FDA-registered device maker in Somersworth, NH, United States, 2 510(k) clearances

Name: Life Science Outsourcing FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Life Science Outsourcing is registered with the FDA (registration 1221051) in Somersworth, NH, United States. It lists 22 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 27, 2018. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 1221051
Address: 25 Centre RD., Somersworth, NH, United States, 03878
Owner or operator: Life Science Outsourcing (10034516)
Roles: Contract manufacturer, Contract sterilizer, Repackager or relabeler
First device listed: December 8, 2010
Registered through: 2026
Brand names listed: Bioabsorbable Anchor, Clip, Iris Retractor, Fluorescence Imaging For Breast Cancer Detection - Lumicell Direct Visualization System (DVS), Gentuity HF-OCT Imaging System With Vis-Rx Micro-Imaging Catheter, Lapiplasty, LevaLap Laparoscopic Access Device, MAXX PRP, PROLENE (Polypropylene) 3D Patch and more

Devices it lists

Device	Product code	Class	Role	Source
Barrier, Synthetic, Intraoral	NPK	2	Contract manufacturer, Contract sterilizer	accessdata.fda.gov
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	DWF	2	Contract manufacturer	accessdata.fda.gov
Clip, Iris Retractor	HOC	1	Contract manufacturer	accessdata.fda.gov
Dispenser, Cement	KIH	1	Contract manufacturer	accessdata.fda.gov
Fastener, Fixation, Biodegradable, Soft Tissue	MAI	2	Contract manufacturer, Contract sterilizer	accessdata.fda.gov
Fluorescence Imaging For Breast Cancer Detection	SAW	3	Contract manufacturer, Contract sterilizer	accessdata.fda.gov
Guide, Surgical, Instrument	FZX	1	Contract manufacturer	accessdata.fda.gov
Insufflator, Laparoscopic	HIF	2	Contract manufacturer	accessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, Cervical	ODP	2	Repackager or relabeler	accessdata.fda.gov
Mesh, Surgical, Polymeric	FTL	2	Contract manufacturer	accessdata.fda.gov
Needle, Aspiration And Injection, Disposable	GAA	1	Repackager or relabeler	accessdata.fda.gov
Passer	HWQ	1	Contract manufacturer	accessdata.fda.gov
Plate, Fixation, Bone	HRS	2	Contract manufacturer	accessdata.fda.gov
Platelet And Plasma Separator For Bone Graft Handling	ORG	2	Contract manufacturer	accessdata.fda.gov
Screw, Fixation, Bone	HWC	2	Contract manufacturer	accessdata.fda.gov
Shunt, Central Nervous System And Components	JXG	2	Contract manufacturer	accessdata.fda.gov
Specimen/Tissue, Identification Orientation	MJI	1	Repackager or relabeler	accessdata.fda.gov
Suture, Nonabsorbable, Silk	GAP	2	Repackager or relabeler	accessdata.fda.gov
Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile	GAQ	2	Repackager or relabeler	accessdata.fda.gov
Suture, Nonabsorbable, Synthetic, Polyamide	GAR	2	Repackager or relabeler	accessdata.fda.gov
Suture, Nonabsorbable, Synthetic, Polyethylene	GAT	2	Contract sterilizer, Repackager or relabeler	accessdata.fda.gov
System, Imaging, Optical Coherence Tomography (Oct)	NQQ	2	Contract manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
June 27, 2018	K180364	HD LifeSciences Cervical IBFD System	ODP	Substantially Equivalent	Hd Lifesciences, LLC	accessdata.fda.gov
January 7, 1994	K931271	ETHI-PACK* SURGICAL STAINLESS STEEL SUTURE	GAQ	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov

Compare with other makers

Updated June 27, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.