Gimmi GmbH: FDA clearances and approvals
Gimmi GmbH has 7 FDA 510(k) clearances (first 2001, latest 2026), across 6 product codes in 5 review panels. Median 510(k) review time: 129 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 1 | 103 |
Review time against the same product codes
Since 2017, Gimmi GmbH's cleared 510(k)s took a median 103 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 122 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HIH | Hysteroscope (And Accessories) | 2 | 2 |
| EOQ | Bronchoscope (Flexible Or Rigid) | 1 | 1 |
| FET | Endoscopic Video Imaging System/Component, Gastroenterology-Urology | 1 | 1 |
| GCT | Light Source, Endoscope, Xenon Arc | 1 | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| HCH | Clip, Aneurysm | 1 | 1 |
Review panels
- Gastroenterology and Urology (2)
- Obstetrics and Gynecology (2)
- Ear, Nose and Throat (1)
- Neurology (1)
- General and Plastic Surgery (1)
Most recent Gimmi GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261179 | AlphaTriPart - Monopolar MIC Instruments | GEI | 2026-07-22 | 103 |
| K092421 | ALPHAHYSTEROSCOPE, FIBEROPTIC, OPERATIVE AND DIAGNOSTIC | HIH | 2010-02-12 | 189 |
| K093125 | ALPHAXENON LIGHT 180 W AND 300 W | GCT | 2010-01-27 | 117 |
| K081640 | GIMMI ANEURYSM CLIPS AND APPLYING FORCEPS | HCH | 2009-05-06 | 329 |
| K012869 | GIMMI ALPHA HYSTEROSCOPES & ACCESSORIES, MODELS E.8XXX.XX, T.8XXX.XX, ZXXX.XX,S.XXXX.XX, K0142.25 | HIH | 2002-03-11 | 196 |
| K012660 | GIMMI'ALPHA' ENDOSCOPES & ACCESSORIES | FET | 2001-12-20 | 129 |
| 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 | EOQ | 2001-11-27 | 18 |
Recalls
openFDA lists no recalls under a recalling firm named Gimmi GmbH.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Gimmi GmbH have?
Gimmi GmbH has 7 FDA 510(k) clearances (first 2001, latest 2026), across 6 product codes in 5 review panels.
How long does FDA take to clear Gimmi GmbH's 510(k)s?
The median time from FDA receipt to decision across Gimmi GmbH's cleared 510(k)s is 129 days.
What devices does Gimmi GmbH make?
Its most frequent FDA product codes are HIH (Hysteroscope (And Accessories), 2); EOQ (Bronchoscope (Flexible Or Rigid), 1); FET (Endoscopic Video Imaging System/Component, Gastroenterology-Urology, 1).
Has Gimmi GmbH had device recalls?
openFDA lists no recalls under a recalling firm name matching Gimmi GmbH. Related entities may recall under other names.
Next steps
- See all 7 Gimmi GmbH clearances with predicates and recalls
- Run predicate analysis for product code HIH, Gimmi GmbH's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.