FDA product code NAY: System, Surgical, Computer Controlled Instrument
NAY is the FDA product code for system, surgical, computer controlled instrument. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the General and Plastic Surgery panel. FDA has cleared 162 510(k) submissions under NAY, 40 in the last five years, from 6 different applicants. The average 510(k) review took 140 days (median 112); 132 days on average over the last three years. FDA has posted 245 recalls for NAY devices, 68 initiated in the last five years.
Definition
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Classification
| Field | Value |
|---|---|
| Device name | System, Surgical, Computer Controlled Instrument |
| 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 NAY
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 16 | 117 |
| 2018 | 15 | 160 |
| 2019 | 8 | 96 |
| 2020 | 9 | 213 |
| 2021 | 11 | 87 |
| 2022 | 6 | 81 |
| 2023 | 5 | 118 |
| 2024 | 10 | 133 |
| 2025 | 16 | 138 |
| 2026 | 3 | 125 |
Top NAY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Intuitive Surgical, Inc. | 136 | 2026-03-11 |
| Transenterix, Inc. | 9 | 2021-03-02 |
| Intuitive Surgical | 8 | 2024-05-24 |
| Asensus Surgical, Inc. | 5 | 2024-07-19 |
| Aktormed GmbH | 2 | 2020-12-22 |
1 more applicants have NAY clearances. See the full list in Caduvo.
Most recent NAY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253986 | Intuitive Surgical, Inc. | da Vinci Force Feedback Instruments | 2026-03-11 | 89 |
| K253556 | Intuitive Surgical, Inc. | da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator | 2026-01-16 | 63 |
| K251739 | Intuitive Surgical, Inc. | da Vinci Surgical System (IS5000) | 2026-01-16 | 224 |
| K252675 | Intuitive Surgical, Inc. | da Vinci SP Surgical System (SP1098) | 2025-12-15 | 112 |
| K252069 | Intuitive Surgical, Inc. | da Vinci SP Surgical System (SP1098) | 2025-12-02 | 154 |
Recalls for NAY devices
245 product recalls in 110 recall events; 68 initiated in the last five years and 74 still open. Most recent: 2026-04-02.
| Year | Recalls |
|---|---|
| 2017 | 19 |
| 2018 | 11 |
| 2019 | 9 |
| 2021 | 3 |
| 2022 | 7 |
| 2023 | 5 |
| 2024 | 42 |
| 2025 | 11 |
| 2026 | 2 |
Frequently asked questions
What is FDA product code NAY?
NAY is the FDA product code for system, surgical, computer controlled instrument. 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 NAY?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
How long does a 510(k) take for product code NAY?
Across 162 cleared submissions the average was 140 days from receipt to decision (median 112).
Which companies have the most NAY clearances?
Intuitive Surgical, Inc. (136); Transenterix, Inc. (9); Intuitive Surgical (8); Asensus Surgical, Inc. (5); Aktormed GmbH (2).
Have NAY devices been recalled?
Yes: 245 product recalls across 110 recall events; the most recent began 2026-04-02.
Next steps
- Run an FDA pathway report with predicate devices for product code NAY
- Run a recall and safety report across every NAY manufacturer
- Watch product code NAY 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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