FDA product code GGX: Pipette, Sahli
GGX is the FDA product code for pipette, sahli. It is a Class I device, regulated under 21 CFR 864.6160 and reviewed by the Hematology panel. FDA has cleared 2 510(k) submissions under GGX, from 2 different applicants. The average 510(k) review took 75 days (median 75).
Classification
| Field | Value |
|---|---|
| Device name | Pipette, Sahli |
| Device class | Class I |
| Regulation | 21 CFR 864.6160 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GGX clearance
Top GGX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Trimedyne, Inc. | 1 | 1990-07-23 |
| Catachem, Inc. | 1 | 1989-10-12 |
Most recent GGX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K902263 | Trimedyne, Inc. | OPTILASE MODEL 1000 ND:YAG LASER ADD'L INDICATION | 1990-07-23 | 63 |
| K894389 | Catachem, Inc. | CREATININE FOR MANUAL OR AUTOMATED APPLICATIONS | 1989-10-12 | 87 |
Recalls for GGX devices
openFDA lists no recalls for product code GGX.
Frequently asked questions
What is FDA product code GGX?
GGX is the FDA product code for pipette, sahli. It is a Class I device, regulated under 21 CFR 864.6160 and reviewed by the Hematology panel.
What device class is GGX?
Class I, regulation 21 CFR 864.6160. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GGX?
Across 2 cleared submissions the average was 75 days from receipt to decision (median 75).
Which companies have the most GGX clearances?
Trimedyne, Inc. (1); Catachem, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GGX
- Run a recall and safety report across every GGX manufacturer
- Watch product code GGX for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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