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Novus™ NL8509021

by Integra Lifesciences Corp.

Novus™ NL8509021 is a Class II device made by Integra Lifesciences Corp., cleared under FDA 510(k) K153041 on 14 Mar 2016 (1 earlier submission) and listed in FDA GUDID since 22 Sep 2015 (UDI-DI 10381780071747), active as of 23 Oct 2026.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK153041 Date14 Mar 2016DecidedStatusActive
United StatesGUDID listing Number10381780071747 UDI-DI Date22 Sep 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K153041 decided 14 Mar 2016 Active· +1 more in the status table
  • FDA GUDID UDI-DI 10381780071747 listed 22 Sep 2015 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K961859
  2. Listed FDA GUDID 10381780071747
  3. Cleared FDA 510(k) K153041

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Novus™
Generic name
Cerebrospinal fluid shunt valve
Model / Ref / Catalog
NL8509021
Primary DI / UDI-DI
10381780071747
510(k) Number
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

Related devices

Category: Cerebrospinal fluid shunt valve

Cleared under the same submission (K153041)

and 8 more cleared under K153041

Cleared under the same submission (K961859)

and 3 more cleared under K961859

Similar devices in this category

Other devices filed under Cerebrospinal fluid shunt valve.

Other devices from Integra Lifesciences Corp.

See all devices from Integra Lifesciences Corp. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)