FDA product code EPT: Microscope, Surgical
EPT is the FDA product code for microscope, surgical. It is a Class I device, regulated under 21 CFR 878.4700 and reviewed by the General and Plastic Surgery panel. FDA has cleared 18 510(k) submissions under EPT, from 11 different applicants. The average 510(k) review took 60 days (median 41). FDA has posted 14 recalls for EPT devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Microscope, Surgical |
| Device class | Class I |
| Regulation | 21 CFR 878.4700 |
| 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 EPT clearance
Top EPT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Storz Instrument Co. | 4 | 1990-09-20 |
| Carl Zeiss, Inc. | 3 | 1994-07-01 |
| Kelleher Corp. | 2 | 1982-08-06 |
| Jedmed Instrument Co. | 2 | 1981-02-04 |
| Microdyne, Inc. | 1 | 1993-11-18 |
6 more applicants have EPT clearances. See the full list in Caduvo.
Most recent EPT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K942233 | Carl Zeiss, Inc. | MKM (MULTIPLE COORDINATE MANIPULATOR) SYSTEM | 1994-07-01 | 53 |
| K931284 | Microdyne, Inc. | MICRODYNE OFFICE SURGICAL MICROSCOPE | 1993-11-18 | 280 |
| K933310 | Micrins Surgical, Inc. | MICRINS CONTRAST BACKGROUND MATERIAL | 1993-08-19 | 43 |
| K903412 | Storz Instrument Co. | STORZ MODEL M705 AND/OR M706 CEILING MOUNTED MICR. | 1990-09-20 | 52 |
| K883581 | Carl Zeiss, Inc. | OPMI CS | 1988-09-13 | 22 |
Recalls for EPT devices
14 product recalls in 11 recall events; 2 initiated in the last five years and 3 still open. Most recent: 2022-11-21.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2018 | 2 |
| 2019 | 3 |
| 2020 | 1 |
| 2022 | 2 |
Frequently asked questions
What is FDA product code EPT?
EPT is the FDA product code for microscope, surgical. It is a Class I device, regulated under 21 CFR 878.4700 and reviewed by the General and Plastic Surgery panel.
What device class is EPT?
Class I, regulation 21 CFR 878.4700. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EPT?
Across 18 cleared submissions the average was 60 days from receipt to decision (median 41).
Which companies have the most EPT clearances?
Storz Instrument Co. (4); Carl Zeiss, Inc. (3); Kelleher Corp. (2); Jedmed Instrument Co. (2); Microdyne, Inc. (1).
Have EPT devices been recalled?
Yes: 14 product recalls across 11 recall events; the most recent began 2022-11-21.
Next steps
- Run an FDA pathway report with predicate devices for product code EPT
- Run a recall and safety report across every EPT manufacturer
- Watch product code EPT 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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