# K013731: Gimmi Alpha Sinuscopes Model # E.8282.01/31/71 + E.8284.01/31/71; Gimmi Alpha Bronchoscopes Model # E.8189.00/01/02/03

- Pathway: 510(k) (Traditional)
- Applicant: Gimmi GmbH
- Decided: Nov 27, 2001 after 18 days
- Product code: EOQ (Bronchoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Henke-Sass Wolf, GmbH: named in the summary without a submission number
- (no number) Optus, Inc.: named in the summary without a submission number
- (no number) Karl Storz Endoscopy: named in the summary without a submission number
- (no number) a wide range of other manufacturers: named in the summary without a submission number

## Indications for use
GIMMI ALPHA® Bronchoscopes are intended to provide qualified physicians with a means for performing endoscopic diagnostic and therapeutic surgical procedures of the larynx and tracheobronchial tree. GIMMI ALPHA® Sinuscopes are intended to provide qualified physicians with a means for performing endoscopic diagnostic and therapeutic sinus surgical procedures.

Source page: https://510kreport.com/device/K013731
Methodology: https://510kreport.com/methodology