FDA product code GEJ: Carrier, Ligature
GEJ is the FDA product code for carrier, ligature. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel. FDA has cleared 5 510(k) submissions under GEJ, 1 in the last five years, from 4 different applicants. The average 510(k) review took 48 days (median 50); 101 days on average over the last three years. FDA has posted 4 recalls for GEJ devices.
Classification
| Field | Value |
|---|---|
| Device name | Carrier, Ligature |
| Device class | Class I |
| Regulation | 21 CFR 878.4800 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
510(k) clearances per year for GEJ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2024 | 1 | 101 |
Compare with all 510(k) review times · Search every GEJ clearance
Top GEJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Solos Endoscopy, Inc. | 2 | 1990-04-18 |
| Cypris Medical | 1 | 2024-05-03 |
| Cook Ob/Gyn | 1 | 1988-11-14 |
| Cox-Uphuff Intl. | 1 | 1987-11-13 |
Most recent GEJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K240185 | Cypris Medical | Cypris eXact Suture Placement Device | 2024-05-03 | 101 |
| K900959 | Solos Endoscopy, Inc. | GS-1400 TOOTHED DISSECTING FORCEP, 5MM, INSULATED | 1990-04-18 | 50 |
| K900958 | Solos Endoscopy, Inc. | GS-1300 ATRAUMATIC GRASPING FORCEP, CURVED, 10MM | 1990-04-18 | 50 |
| K884553 | Cook Ob/Gyn | STAMEY NEEDLE | 1988-11-14 | 14 |
| K874342 | Cox-Uphuff Intl. | LIGATURE CARRIER/PACKER, HYDROXYLAPATITE | 1987-11-13 | 24 |
Recalls for GEJ devices
4 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-04-25.
| Year | Recalls |
|---|---|
| 2017 | 3 |
Frequently asked questions
What is FDA product code GEJ?
GEJ is the FDA product code for carrier, ligature. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel.
What device class is GEJ?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GEJ?
Across 5 cleared submissions the average was 48 days from receipt to decision (median 50).
Which companies have the most GEJ clearances?
Solos Endoscopy, Inc. (2); Cypris Medical (1); Cook Ob/Gyn (1); Cox-Uphuff Intl. (1).
Have GEJ devices been recalled?
Yes: 4 product recalls across 2 recall events; the most recent began 2017-04-25.
Next steps
- Run an FDA pathway report with predicate devices for product code GEJ
- Run a recall and safety report across every GEJ manufacturer
- Watch product code GEJ 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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