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Codman® 9190002RPB

by Integra LifeSciences Production Corporation

Codman® 9190002RPB is a Class II device made by Integra LifeSciences Production Corporation, cleared under FDA 510(k) K163106 on 1 Dec 2016 and listed in FDA GUDID since 1 Apr 2020 (UDI-DI 10381780521785), 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 Number10381780521785 UDI-DI Date1 Apr 2020ListedStatusListed 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 10381780521785 listed 1 Apr 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K163106
  2. Listed FDA GUDID 10381780521785

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  • Withdrawn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
Electrical-only medical device connection cable, single-use
Model / Ref / Catalog
9190002RPB
Primary DI / UDI-DI
10381780521785
510(k) Number
FDA product code
GEI
GMDN term
Electrical-only medical device connection cable, single-use
Device class
Class II
Regulation number
878.4400
GUDID distribution status
In Commercial Distribution
Sterilisation method
Ethylene Oxide

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Properties

  • Sterilise before use
  • Single use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (10, all answered No)