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TruClear 72203606

by Covidien LP

TruClear 72203606 is a hysteroscopic irrigation/insufflation system (FDA Class II; FDA product code HIH, Hysteroscope (and Accessories)) made by Covidien LP, cleared under FDA 510(k) K013870 on 17 Jan 2002 and listed in FDA GUDID since 15 Apr 2024 (UDI-DI 10884521744141), 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) K013870

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 Number10884521744141 UDI-DI Date15 Apr 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK013870 Date17 Jan 2002DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K013870 decided 17 Jan 2002 Active
  • FDA GUDID UDI-DI 10884521744141 listed 15 Apr 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K013870
  2. Listed FDA GUDID 10884521744141

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
TruClear
Generic name
Hysteroscopic irrigation/insufflation system
Model / reference
72203606
Primary DI / UDI-DI
10884521744141
510(k) Number
FDA product code
HIH
GMDN term
Hysteroscopic irrigation/insufflation system
Device class
Class II
Regulation number
884.1690
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
Size
Length — 4.0 Millimeter

Similar devices

Other devices filed under FDA product code HIH (HYSTEROSCOPE (AND ACCESSORIES)).

Other devices from Covidien LP

  • LigaSure MRASILF19

    Class II
  • Shiley 110860

    Class II
  • Shiley 110865

    Class II
  • Shiley 110870

    Class II

See all devices from Covidien LP →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (11, all answered No)