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SPY-PHI System HH9001

by Novadaq Technologies Inc

SPY-PHI System HH9001 (HH9006) is a general surgical procedure kit (FDA Class II; FDA product code OWN, Confocal optical imaging) made by Novadaq Technologies Inc, cleared under FDA 510(k) K190729 on 19 Apr 2019 and listed in FDA GUDID since 31 Mar 2017 (UDI-DI 10858701006282), 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) K190729

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESD from GUDID Substantially Equivalent — Deferred · Special NumberK190729 Date19 Apr 2019DecidedStatusActive
United StatesGUDID listing Number10858701006282 UDI-DI Date31 Mar 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K190729 decided 19 Apr 2019 Active
  • FDA GUDID UDI-DI 10858701006282 listed 31 Mar 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10858701006282
  2. Cleared FDA 510(k) K190729

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
SPY-PHI System
Generic name
General surgical procedure kit, medicated
Model / Ref / Catalog
HH9001, HH9006
Primary DI / UDI-DI
10858701006282
510(k) Number
FDA product code
OWN
GMDN term
General surgical procedure kit, medicated
Device class
Class II
Regulation number
876.1500
GUDID distribution status
In Commercial Distribution

Related devices

Category: General surgical procedure kit, medicated

Similar devices

Other devices filed under FDA product code OWN (Confocal optical imaging).

Other devices from Novadaq Technologies Inc

See all devices from Novadaq Technologies Inc →

Properties

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