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HighSurg 11 3361

by Nouvag AG

HighSurg 11 3361 is a Class II device made by Nouvag AG, cleared under FDA 510(k) K042434 on 3 Nov 2004 and listed in FDA GUDID since 13 Jan 2017 (UDI-DI ENOU33610), 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) K042434

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 NumberENOU33610 UDI-DI Date13 Jan 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK042434 Date3 Nov 2004DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K042434 decided 3 Nov 2004 Active
  • FDA GUDID UDI-DI ENOU33610 listed 13 Jan 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K042434
  2. Listed FDA GUDID ENOU33610

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
HighSurg 11
Generic name
Line-powered surgical power tool system motor
Model / reference
3361
Primary DI / UDI-DI
ENOU33610
510(k) Number
FDA product code
HBC, ERL
GMDN term
Line-powered surgical power tool system motor
Device class
Class II
Regulation number
882.4360, 874.4250
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Line-powered surgical power tool system motor

Cleared under the same submission (K042434)

and 8 more cleared under K042434

Similar devices

Other devices filed under FDA product code HBC (Motor, Drill, Electric).

Other devices from Nouvag AG

See all devices from Nouvag AG →

Properties

  • Sterilise before use
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)