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Nuvis 140-4010-1

by Integrated Endoscopy, Inc.

Nuvis 140-4010-1 is a Class II device made by Integrated Endoscopy, Inc., cleared under FDA 510(k) K140903 on 17 Jul 2014 and listed in FDA GUDID since 8 Feb 2018 (UDI-DI 08538160080010), 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) K140903

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 Number08538160080010 UDI-DI Date8 Feb 2018ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK140903 Date17 Jul 2014DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K140903 decided 17 Jul 2014 Active
  • FDA GUDID UDI-DI 08538160080010 listed 8 Feb 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K140903
  2. Listed FDA GUDID 08538160080010

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Nuvis
Generic name
Rigid optical arthroscope, reusable
Model / Ref / Catalog
140-4010-1
Primary DI / UDI-DI
08538160080010
510(k) Number
FDA product code
HRX
GMDN term
Rigid optical arthroscope, reusable
Device class
Class II
Regulation number
888.1100
GUDID distribution status
Not in Commercial Distribution
Size
Angle — 30 degree
Outer Diameter — 4 Millimeter
Length — 140 Millimeter

Similar devices

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

Other devices from Integrated Endoscopy, Inc.

See all devices from Integrated Endoscopy, Inc. →

Properties

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