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Codman® 9190001GF

by Integra LifeSciences Switzerland Sàrl 2 variants

Codman® 9190001GF is a Class II device made by Integra LifeSciences Switzerland Sàrl, cleared under FDA 510(k) K163106 on 1 Dec 2016 and listed in FDA GUDID since 15 Apr 2026 (UDI-DI 10381780542247), 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

510(k) K163106

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10381780542247 UDI-DI Date15 Apr 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK163106 Date1 Dec 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K163106 decided 1 Dec 2016 Active
  • FDA GUDID UDI-DI 10381780542247 listed 15 Apr 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K163106
  2. Listed FDA GUDID 10381780542247

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Codman®
Generic name
Ventricular cerebrospinal fluid drainage catheterization kit
Model / Ref / Catalog
9190001GF
Primary DI / UDI-DI
10381780542247
510(k) Number
FDA product code
GEI
GMDN term
Ventricular cerebrospinal fluid drainage catheterization kit
Device class
Class II
Regulation number
878.4400
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K163106)

and 2 more cleared under K163106

Other devices from Integra LifeSciences Switzerland Sàrl

See all devices from Integra LifeSciences Switzerland Sàrl →

Properties

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