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Aed 27026CA

by National Advanced Endoscopy Devices, Inc.

Aed 27026CA is a Class II device made by National Advanced Endoscopy Devices, Inc., cleared under FDA 510(k) K993689 on 15 Dec 1999 and listed in FDA GUDID since 20 Nov 2017 (UDI-DI 00848657015615), active (FDA 510(k)), not in commercial distribution (GUDID) as of 23 Oct 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

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) K993689

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 Number00848657015615 UDI-DI Date20 Nov 2017ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK993689 Date15 Dec 1999DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K993689 decided 15 Dec 1999 Active
  • FDA GUDID UDI-DI 00848657015615 listed 20 Nov 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K993689
  2. Listed FDA GUDID 00848657015615

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  • Withdrawn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
27026CA
Primary DI / UDI-DI
00848657015615
510(k) Number
FDA product code
FAJ
GMDN term
Endoscope sheath, reusable
Device class
Class II
Regulation number
876.1500
GUDID distribution status
Not in Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Cleared under the same submission (K993689)

and 8 more cleared under K993689

Similar devices

Other devices filed under FDA product code FAJ (Cystoscope and accessories, flexible/rigid).

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)