FDA product code FTD: Lamp, Surgical
FTD is the FDA product code for lamp, surgical. It is a Class II device, regulated under 21 CFR 878.4580 and reviewed by the General and Plastic Surgery panel. FDA has cleared 29 510(k) submissions under FTD, from 24 different applicants. The average 510(k) review took 70 days (median 46). FDA has posted 49 recalls for FTD devices, 8 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Lamp, Surgical |
| Device class | Class II |
| Regulation | 21 CFR 878.4580 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every FTD clearance
Top FTD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Engineered Medical Solutions Co., LLC | 2 | 2013-12-05 |
| AtriCure, Inc. | 2 | 2011-06-09 |
| Stryker Instruments | 2 | 1998-06-30 |
| Burton Medical Products Corp. | 2 | 1994-06-23 |
| Fiber Optics Engineering, Inc. | 2 | 1977-04-14 |
19 more applicants have FTD clearances. See the full list in Caduvo.
Most recent FTD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K133425 | Engineered Medical Solutions Co., LLC | SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGICAL LIGHT | 2013-12-05 | 27 |
| K130513 | Maquet S.A.S. | VOLISTA 400; VOLISTA 600 | 2013-05-08 | 70 |
| K123776 | Drager Medical GmbH | POLARIS 100/200 | 2013-03-08 | 88 |
| K111020 | AtriCure, Inc. | ATRICURE DISSECTOR | 2011-06-09 | 58 |
| K100234 | Hillusa, Inc. | HM-LAMP II | 2010-07-08 | 163 |
Recalls for FTD devices
49 product recalls in 14 recall events; 8 initiated in the last five years and 8 still open. Most recent: 2024-06-04.
| Year | Recalls |
|---|---|
| 2018 | 2 |
| 2019 | 13 |
| 2023 | 6 |
| 2024 | 2 |
Frequently asked questions
What is FDA product code FTD?
FTD is the FDA product code for lamp, surgical. It is a Class II device, regulated under 21 CFR 878.4580 and reviewed by the General and Plastic Surgery panel.
What device class is FTD?
Class II, regulation 21 CFR 878.4580. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FTD?
Across 29 cleared submissions the average was 70 days from receipt to decision (median 46).
Which companies have the most FTD clearances?
Engineered Medical Solutions Co., LLC (2); AtriCure, Inc. (2); Stryker Instruments (2); Burton Medical Products Corp. (2); Fiber Optics Engineering, Inc. (2).
Have FTD devices been recalled?
Yes: 49 product recalls across 14 recall events; the most recent began 2024-06-04.
Next steps
- Run an FDA pathway report with predicate devices for product code FTD
- Run a recall and safety report across every FTD manufacturer
- Watch product code FTD 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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