Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040 +…

FDA 510(k)

Class II (US FDA 510(k))

510(k) K243820

Identifiers

510(k) Number: K243820 FDA 510(k)
FDA Product Code: FED FDA 510(k)
Models / Variants: Hoover Model #'s IVX-NS-1040 FDA 510(k)
IVX-NS-1050 FDA 510(k)
IVX-NS-1140 FDA 510(k)
IVX-NS-1150 FDA 510(k)
IVX-NS-1240 FDA 510(k)
IVX-NS-1250 FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 876.1500 FDA 510(k)
Regulation Number: 876.1500 FDA 510(k)
Advisory Committee: Gastroenterology, Urology FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040 +… by Dornier MedTech America, Inc. — Class II — FDA_510K — listed in FDA 510(k)…

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K243820	Class II	Active

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Dornier MedTech America, Inc.
FDA Applicant: Dornier Medtech America

Sources (1)

FDA 510(k) K243820 24 fields · synced Jun 18, 2026