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Aed 5710A-Xxl

by National Advanced Endoscopy Devices, Inc.

Aed 5710A-Xxl is a rigid optical laparoscope (FDA Class II; FDA product code GCJ, Laparoscope, general & plastic surgery) made by National Advanced Endoscopy Devices, Inc., cleared under FDA 510(k) K993688 on 6 Dec 1999 and listed in FDA GUDID since 28 Apr 2017 (UDI-DI 00848657002820), 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) K993688

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 Number00848657002820 UDI-DI Date28 Apr 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK993688 Date6 Dec 1999DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K993688 decided 6 Dec 1999 Active
  • FDA GUDID UDI-DI 00848657002820 listed 28 Apr 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K993688
  2. Listed FDA GUDID 00848657002820

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  • Withdrawn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
Rigid optical laparoscope
Model / reference
5710A-XXL
Primary DI / UDI-DI
00848657002820
510(k) Number
FDA product code
GCJ
GMDN term
Rigid optical laparoscope
Device class
Class II
Regulation number
876.1500
GUDID distribution status
In Commercial Distribution

Related devices

Category: Rigid optical laparoscope

Cleared under the same submission (K993688)

and 8 more cleared under K993688

Similar devices in this category

Other devices filed under Rigid optical laparoscope.

Other devices from National Advanced Endoscopy Devices, Inc.

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    Class II

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    Class II

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    Class II

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

Properties

  • Prescription use
  • Lot / batch number
  • Serial number
Other properties (12, all answered No)