FDA product code OTJ: Laparoscopic Single Port Access Device
OTJ is the FDA product code for laparoscopic single port access device. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the General and Plastic Surgery panel. FDA has cleared 11 510(k) submissions under OTJ, 2 in the last five years, from 8 different applicants. The average 510(k) review took 174 days (median 156); 189 days on average over the last three years.
Definition
A multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery.
Classification
| Field | Value |
|---|---|
| Device name | Laparoscopic Single Port Access Device |
| Device class | Class II |
| Regulation | 21 CFR 876.1500 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
510(k) clearances per year for OTJ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 1 | 394 |
| 2022 | 1 | 261 |
| 2024 | 1 | 189 |
Compare with all 510(k) review times · Search every OTJ clearance
Top OTJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Advanced Surgical Concepts | 4 | 2012-09-06 |
| Dalim Medical Corp. | 1 | 2024-01-16 |
| Incore Co., Ltd. | 1 | 2022-09-28 |
| Afs Medical Co. , Ltd. | 1 | 2021-10-14 |
| Fortimedix Surgical B.V. | 1 | 2016-08-26 |
3 more applicants have OTJ clearances. See the full list in Caduvo.
Most recent OTJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K232062 | Dalim Medical Corp. | Uni-port | 2024-01-16 | 189 |
| K220081 | Incore Co., Ltd. | CORE-SPORT | 2022-09-28 | 261 |
| K202688 | Afs Medical Co. , Ltd. | AFS Medical Sterile Single-Use Access Port System | 2021-10-14 | 394 |
| K160797 | Fortimedix Surgical B.V. | FMX314 Surgical Platform | 2016-08-26 | 156 |
| K152598 | Nelis | Endo Keeper | 2016-03-17 | 188 |
Recalls for OTJ devices
openFDA lists no recalls for product code OTJ.
Frequently asked questions
What is FDA product code OTJ?
OTJ is the FDA product code for laparoscopic single port access device. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the General and Plastic Surgery panel.
What device class is OTJ?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
How long does a 510(k) take for product code OTJ?
Across 11 cleared submissions the average was 174 days from receipt to decision (median 156).
Which companies have the most OTJ clearances?
Advanced Surgical Concepts (4); Dalim Medical Corp. (1); Incore Co., Ltd. (1); Afs Medical Co. , Ltd. (1); Fortimedix Surgical B.V. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OTJ
- Run a recall and safety report across every OTJ manufacturer
- Watch product code OTJ 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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