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SECQURE Ultimate CQ3850ULT

by Secqure Surgical, Corp.

SECQURE Ultimate CQ3850ULT is a Class II device made by Secqure Surgical, Corp., cleared under FDA 510(k) K081398 on 6 Feb 2009 and listed in FDA GUDID since 19 Sep 2017 (UDI-DI 00863634000484), active as of 22 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 22 Oct 2026

Documents

510(k) K081398

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 Number00863634000484 UDI-DI Date19 Sep 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK081398 Date6 Feb 2009DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K081398 decided 6 Feb 2009 Active
  • FDA GUDID UDI-DI 00863634000484 listed 19 Sep 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K081398
  2. Listed FDA GUDID 00863634000484

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
SECQURE Ultimate
Generic name
Surgical irrigation/aspiration tubing set
Model / reference
CQ3850ULT
Primary DI / UDI-DI
00863634000484
510(k) Number
FDA product code
HET
GMDN term
Surgical irrigation/aspiration tubing set
Device class
Class II
Regulation number
884.1720
GUDID distribution status
In Commercial Distribution

Related devices

Category: Surgical irrigation/aspiration tubing set

Cleared under the same submission (K081398)

and 5 more cleared under K081398

Similar devices in this category

Other devices filed under Surgical irrigation/aspiration tubing set.

Other devices from Secqure Surgical, Corp.

See all devices from Secqure Surgical, Corp. →

Properties

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