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Pinpoint PC9004

by Novadaq Technologies Inc

Pinpoint PC9004 is a fibreoptic light cable (FDA Class II; FDA product code GCJ, Laparoscope, general & plastic surgery) made by Novadaq Technologies Inc, cleared under FDA 510(k) K150956 on 23 May 2016 and listed in FDA GUDID since 12 Dec 2018 (UDI-DI 00858701006568), active as of 22 Oct 2026. One FDA recall is linked to it.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

510(k) K150956

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00858701006568 UDI-DI Date12 Dec 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK150956 Date23 May 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K150956 decided 23 May 2016 Active
  • FDA GUDID UDI-DI 00858701006568 listed 12 Dec 2018 Listed

Recalls

1 recall · FDA

    • Terminated Z-1428-2021 FDA Class II initiated 26 Feb 2021

    Their is a potential that Video Processor/Illuminators may exhibit flickering, loss of image or unintended reboots.

Timeline

3 dated events

  1. Cleared FDA 510(k) K150956
  2. Listed FDA GUDID 00858701006568
  3. Recall initiated FDA recalls Z-1428-2021

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Pinpoint
Generic name
Fibreoptic light cable, reusable
Model / Ref / Catalog
PC9004
Primary DI / UDI-DI
00858701006568
510(k) Number
FDA product code
GCJ
GMDN term
Fibreoptic light cable, reusable
Device class
Class II
Regulation number
876.1500
GUDID distribution status
In Commercial Distribution

Related devices

Category: Fibreoptic light cable

Similar devices in this category

Other devices filed under Fibreoptic light cable.

Other devices from Novadaq Technologies Inc

See all devices from Novadaq Technologies Inc →

Properties

  • Sterilise before use
  • Prescription use
  • Serial number
Other properties (12, all answered No)