Skip to content

Nuvis Battery Arthroscope

by Integrated Endoscopy, Inc.

510(k) K191594

Nuvis Battery Arthroscope is a Class II device made by Integrated Endoscopy, Inc., cleared under FDA 510(k) K191594 on 11 Jul 2019, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK191594 Date11 Jul 2019ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
HRX
Device class
Class II
Regulation
21 CFR Part 888.1100
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

From the manufacturer

Manufacturer's product page: Download Nuvis IFU English

Devices cleared under K191594

2 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K191594
UDI-DISize and differences
Nuvis IE4030
Integrated Endoscopy, Inc.
IE4030 / IE403000853816008001
Angle 30 deg; Outer Diameter 4 mm; Length 142 mm
On the market
Nuvis IE4030-10
Integrated Endoscopy, Inc.
IE4030-10 / IE4030-1010853816008008
Angle 30 deg; Outer Diameter 4 mm; Length 142 mm
On the market

Similar devices

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

Other devices from Integrated Endoscopy, Inc.

See all devices from Integrated Endoscopy, Inc. →