FDA product code GJW: Pipette, Pasteur
GJW is the FDA product code for pipette, pasteur. It is a Class I device, regulated under 21 CFR 864.6160 and reviewed by the Hematology panel. FDA has cleared 4 510(k) submissions under GJW, from 3 different applicants. The average 510(k) review took 53 days (median 41).
Classification
| Field | Value |
|---|---|
| Device name | Pipette, Pasteur |
| Device class | Class I |
| Regulation | 21 CFR 864.6160 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
Top GJW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Dade, Baxter Travenol Diagnostics, Inc. | 2 | 1977-08-04 |
| Helena Laboratories | 1 | 1990-03-23 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 1 | 1976-11-09 |
Most recent GJW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K896670 | Helena Laboratories | TIP TOP(R) DISPENSER CAPS | 1990-03-23 | 116 |
| K771137 | Dade, Baxter Travenol Diagnostics, Inc. | PIPETS UNIFORM DROP SIZE BOROSILICATE | 1977-08-04 | 41 |
| K771138 | Dade, Baxter Travenol Diagnostics, Inc. | PIPETS BOROSILICATE GLASS | 1977-08-04 | 41 |
| K760899 | Bd Becton Dickinson Vacutainer Systems Preanalytic | STERILE DISPOSABLE COTTON PLUGGED SER. | 1976-11-09 | 14 |
Recalls for GJW devices
openFDA lists no recalls for product code GJW.
Frequently asked questions
What is FDA product code GJW?
GJW is the FDA product code for pipette, pasteur. It is a Class I device, regulated under 21 CFR 864.6160 and reviewed by the Hematology panel.
What device class is GJW?
Class I, regulation 21 CFR 864.6160. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GJW?
Across 4 cleared submissions the average was 53 days from receipt to decision (median 41).
Which companies have the most GJW clearances?
Dade, Baxter Travenol Diagnostics, Inc. (2); Helena Laboratories (1); Bd Becton Dickinson Vacutainer Systems Preanalytic (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GJW
- Run a recall and safety report across every GJW manufacturer
- Watch product code GJW 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.