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Aed 18-2305

by National Advanced Endoscopy Devices, Inc.

Aed 18-2305 is a Class II device made by National Advanced Endoscopy Devices, Inc., cleared under FDA 510(k) K141515 on 7 Jan 2015 and listed in FDA GUDID since 30 Nov 2017 (UDI-DI 00848657016179), 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) K141515

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 Number00848657016179 UDI-DI Date30 Nov 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK141515 Date7 Jan 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K141515 decided 7 Jan 2015 Active
  • FDA GUDID UDI-DI 00848657016179 listed 30 Nov 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K141515
  2. Listed FDA GUDID 00848657016179

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Aed
Generic name
Endoscope sheath, reusable
Model / reference
18-2305
Primary DI / UDI-DI
00848657016179
510(k) Number
FDA product code
HIH
GMDN term
Endoscope sheath, reusable
Device class
Class II
Regulation number
884.1690
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Endoscope sheath, reusable

Cleared under the same submission (K141515)

and 8 more cleared under K141515

Similar devices in this category

Other devices filed under Endoscope sheath, reusable.

Other devices from National Advanced Endoscopy Devices, Inc.

  • Aed AED2718B

    Class II

  • Aed AED2717B

    Class II

  • Aed AED2719B

    Class II

  • Aed 8815SB

    Class II

See all devices from National Advanced Endoscopy Devices, Inc. →

Properties

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