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8300053519

by Henke-Sass, Wolf GmbH

8300053519 is a Class II device made by Henke-Sass, Wolf GmbH, cleared under FDA 510(k) K173070 on 8 Jun 2018 and listed in FDA GUDID since 18 Feb 2021 (UDI-DI 04035873068693), 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) K173070

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 Number04035873068693 UDI-DI Date18 Feb 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK173070 Date8 Jun 2018DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K173070 decided 8 Jun 2018 Active
  • FDA GUDID UDI-DI 04035873068693 listed 18 Feb 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K173070
  2. Listed FDA GUDID 04035873068693

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Resectoscope
Model / Ref / Catalog
8300053519
Primary DI / UDI-DI
04035873068693
510(k) Number
FDA product code
FAJ
GMDN term
Resectoscope
Device class
Class II
Regulation number
876.1500
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Resectoscope

Cleared under the same submission (K173070)

and 8 more cleared under K173070

Similar devices

Other devices filed under FDA product code FAJ (Cystoscope And Accessories, Flexible/Rigid).

Other devices from Henke-Sass, Wolf GmbH

See all devices from Henke-Sass, Wolf GmbH →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
Other properties (12, all answered No)