FDA product code KCJ: Applicator, Ent
KCJ is the FDA product code for applicator, ent. It is a Class I device, regulated under 21 CFR 874.5220 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 4 510(k) submissions under KCJ, from 4 different applicants. The average 510(k) review took 86 days (median 70). FDA has posted 1 recall for KCJ devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Applicator, Ent |
| Device class | Class I |
| Regulation | 21 CFR 874.5220 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every KCJ clearance
Top KCJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ethicon Endo-Surgery, Inc. | 1 | 1992-09-09 |
| Laparomed Corp. | 1 | 1992-08-06 |
| Apdyne Medical Co. | 1 | 1989-10-12 |
| Kells Medical, Inc. | 1 | 1983-09-29 |
Most recent KCJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K923679 | Ethicon Endo-Surgery, Inc. | ENDOPATH TISSUE RETAINING COMPONENT | 1992-09-09 | 49 |
| K921053 | Laparomed Corp. | LAPAROMED LIGATING LOOP | 1992-08-06 | 154 |
| K894369 | Apdyne Medical Co. | APDYNE PHENOL APPLICATOR KIT | 1989-10-12 | 90 |
| K832667 | Kells Medical, Inc. | LUCAE'S EAR & NASAL APPLICATORS | 1983-09-29 | 51 |
Recalls for KCJ devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2024-12-28.
| Year | Recalls |
|---|---|
| 2024 | 1 |
Frequently asked questions
What is FDA product code KCJ?
KCJ is the FDA product code for applicator, ent. It is a Class I device, regulated under 21 CFR 874.5220 and reviewed by the Ear, Nose and Throat panel.
What device class is KCJ?
Class I, regulation 21 CFR 874.5220. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KCJ?
Across 4 cleared submissions the average was 86 days from receipt to decision (median 70).
Which companies have the most KCJ clearances?
Ethicon Endo-Surgery, Inc. (1); Laparomed Corp. (1); Apdyne Medical Co. (1); Kells Medical, Inc. (1).
Have KCJ devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2024-12-28.
Next steps
- Run an FDA pathway report with predicate devices for product code KCJ
- Run a recall and safety report across every KCJ manufacturer
- Watch product code KCJ 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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