Integra® NL8501359

by Integra Lifesciences Corp.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

in data synced 23 Oct 2026

Documents

+1 more

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK153041	Date14 Mar 2016Decided	StatusActive
United States	GUDID listing	Number10381780071488 UDI-DI	Date22 Sep 2015Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK760502	Date30 Aug 1976Decided	StatusActive

Official records

AccessGUDID record UDI-DI 10381780071488
FDA 510(k) database 510(k) number K153041
FDA 510(k) database 510(k) number K760502

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Integra®
Generic name: Cerebrospinal fluid shunt valve
Model / Ref / Catalog: NL8501359

Primary DI / UDI-DI: 10381780071488
510(k) Number: K153041
K760502
FDA product code: JXG
GMDN term: Cerebrospinal fluid shunt valve

Device class: Class II
Regulation number: 882.5550
GUDID distribution status: In Commercial Distribution

MRI safety: MR Conditional

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Properties

Supplied sterile
Single use
Implantable
Prescription use
Lot / batch number
Expiration date

Other properties (9)

Sterilise before use: No
Contains latex: No
Over-the-counter: No
Convenience kit: No
Combination product: No
HCT/P: No
Premarket exempt: No
Serial number: No
Manufacturing date: No