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Urology Set LL0006

by Thermedx, LLC

Urology Set LL0006 is a hysteroscopic irrigation/insufflation system (FDA Class II) made by Thermedx, LLC, cleared under FDA 510(k) K172048 on 5 Sep 2017 and listed in FDA GUDID since 1 Feb 2018 (UDI-DI 00860936000365), 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

1 ongoing

This device is named in the recall

Documents

510(k) K172048

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 Number00860936000365 UDI-DI Date1 Feb 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK172048 Date5 Sep 2017DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K172048 decided 5 Sep 2017 Active
  • FDA GUDID UDI-DI 00860936000365 listed 1 Feb 2018 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2166-2026 FDA Class II initiated 9 Apr 2026

    Due to nonconforming products being inadvertently distributed.

Timeline

3 dated events

  1. Cleared FDA 510(k) K172048
  2. Listed FDA GUDID 00860936000365
  3. Recall initiated FDA recalls Z-2166-2026

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Urology Set
Generic name
Hysteroscopic irrigation/insufflation system
Model / Ref / Catalog
LL0006
Primary DI / UDI-DI
00860936000365
510(k) Number
FDA product code
HRX, LGZ, HIG
GMDN term
Hysteroscopic irrigation/insufflation system
Device class
Class II
Regulation number
888.1100, 880.5725, 884.1700
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Size
Pressure — 400 millibar

Related devices

Category: Hysteroscopic irrigation/insufflation system

Similar devices

Other devices filed under FDA product code HRX (Arthroscope).

Other devices from Thermedx, LLC

See all devices from Thermedx, LLC →

Properties

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