Sipa: FDA-registered device maker in Avesnes Sur Helpe Hauts-de-France, France, 7 510(k) clearances

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

Sipa is registered with the FDA (registration 3002808466) in Avesnes Sur Helpe Hauts-de-France, France. It lists 8 device types. The FDA files 7 510(k) clearances under its listings, the newest dated June 10, 2004. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3002808466
Address: 22 Avenue Stroh, Avesnes Sur Helpe Hauts-de-France, France, 59440
Owner or operator: VYGON S A (8020785)
Roles: Manufacturer
First device listed: January 3, 2008
Registered through: 2026
Brand names listed: Boussignac, Caps and Connectors, Lectospiral, Lectrocath, Nutrisafe 2, Thoracic trocar and drain, Vyclic, Vygon Spinal Anesthesia Needle w/ Introducer and more

Devices it lists

Device	Product code	Class	Role	Source
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	DTL	2	Manufacturer	accessdata.fda.gov
Catheter, Intravascular, Diagnostic	DQO	2	Manufacturer	accessdata.fda.gov
Catheter, Umbilical Artery	FOS	2	Manufacturer	accessdata.fda.gov
Kit, Surgical Instrument, Disposable	KDD	1	Manufacturer	accessdata.fda.gov
Needle, Conduction, Anesthetic (W/Wo Introducer)	BSP	2	Manufacturer	accessdata.fda.gov
Set, Administration, Intravascular	FPA	2	Manufacturer	accessdata.fda.gov
Stand, Infusion	FOX	1	Manufacturer	accessdata.fda.gov
Tube, Tracheal (W/Wo Connector)	BTR	2	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 10, 2004	K040657	BOUSSIGNAC/VYGON ENDOTRACHEAL TUBE, MODEL 6501.25/30/35 AND 6502.70/75/80	BTR	Substantially Equivalent	Vygon SA	accessdata.fda.gov
October 26, 1992	K921352	VYGON POLYURETHANE VENOUS/ARTERIAL XRO UMBIL. CATH	FOS	Substantially Equivalent	Vygon Corp.	accessdata.fda.gov
September 29, 1988	K883612	LECTROSPIRAL	FPA	Substantially Equivalent	Vygon Corp.	accessdata.fda.gov
May 7, 1985	K851478	VYGON SPINAL ANESTHESIA NEEDLE W/INTRODUCER 183	BSP	Substantially Equivalent	Vygon Corp.	accessdata.fda.gov
January 30, 1984	K832628	VYGON THORACIC DRAINAGE-VARIOUS #'S	KDD	Substantially Equivalent	Exco, Inc.	accessdata.fda.gov
November 27, 1981	K813141	VYGON STOPCOCKS & RAMPS(MANIFOLDS)	DTL	Substantially Equivalent	Exco, Inc.	accessdata.fda.gov
November 27, 1981	K813140	VYGON EXTENSION TUBES & CONNECTORS	DQO	Substantially Equivalent	Exco, Inc.	accessdata.fda.gov

Compare with other makers

Updated June 10, 2004. 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.