Skip to content

AccessVu 90 IV-ASY-1609

by Intravu, Inc.

AccessVu 90 IV-ASY-1609 is a Class II device made by Intravu, Inc., cleared under FDA 510(k) K181982 on 21 Aug 2018 and listed in FDA GUDID since 15 Oct 2021 (UDI-DI 00850023905000), 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) K181982

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 Number00850023905000 UDI-DI Date15 Oct 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK181982 Date21 Aug 2018DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K181982 decided 21 Aug 2018 Active
  • FDA GUDID UDI-DI 00850023905000 listed 15 Oct 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K181982
  2. Listed FDA GUDID 00850023905000

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
AccessVu 90
Generic name
Rigid optical arthroscope, single-use
Model / Ref / Catalog
IV-ASY-1609
Description
Disposable accessory kit to be used with IntraVu Scope 90. Kit contains 90mm cannula, 90mm trocar, cannula cap and stopcock.
Primary DI / UDI-DI
00850023905000
510(k) Number
FDA product code
HRX, GCJ
GMDN term
Rigid optical arthroscope, single-use
Device class
Class II
Regulation number
888.1100, 876.1500
GUDID distribution status
In Commercial Distribution
Size
Length — 90 Millimeter

Related devices

Category: Rigid optical arthroscope, single-use

Cleared under the same submission (K181982)

and 5 more cleared under K181982

Similar devices

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

Other devices from Intravu, Inc.

See all devices from Intravu, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)