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Erbe 20132-166

by Erbe Elektromedizin GmbH

Erbe 20132-166 is a Class II device made by Erbe Elektromedizin GmbH, cleared under FDA 510(k) K013348 on 26 Oct 2001 and listed in FDA GUDID since 16 Dec 2016 (UDI-DI 04050147020238), 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) K013348

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 Number04050147020238 UDI-DI Date16 Dec 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK013348 Date26 Oct 2001DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K013348 decided 26 Oct 2001 Active
  • FDA GUDID UDI-DI 04050147020238 listed 16 Dec 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K013348
  2. Listed FDA GUDID 04050147020238

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Erbe
Generic name
Inert gas-enhanced endoscopic electrosurgical electrode, single-use
Model / Ref / Catalog
20132-166
Primary DI / UDI-DI
04050147020238
510(k) Number
FDA product code
GEI
GMDN term
Inert gas-enhanced endoscopic electrosurgical electrode, single-use
Device class
Class II
Regulation number
878.4400
GUDID distribution status
In Commercial Distribution
Size
Length — 3.000 Meter

Similar devices in this category

Other devices filed under Inert gas-enhanced endoscopic electrosurgical electrode, single-use.

Other devices from Erbe Elektromedizin GmbH

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Properties

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