FDA product code KNS: Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
KNS is the FDA product code for unit, electrosurgical, endoscopic (with or without accessories). It is a Class II device, regulated under 21 CFR 876.4300 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 189 510(k) submissions under KNS, 28 in the last five years, from 92 different applicants. The average 510(k) review took 106 days (median 78); 123 days on average over the last three years. FDA has posted 125 recalls for KNS devices, 93 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) |
| Device class | Class II |
| Regulation | 21 CFR 876.4300 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for KNS
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 3 | 101 |
| 2018 | 5 | 134 |
| 2019 | 7 | 133 |
| 2020 | 4 | 216 |
| 2021 | 4 | 148 |
| 2022 | 3 | 188 |
| 2023 | 9 | 109 |
| 2024 | 3 | 150 |
| 2025 | 11 | 165 |
| 2026 | 2 | 54 |
Compare with all 510(k) review times · Search every KNS clearance
Top KNS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Wilson-Cook Medical, Inc. | 11 | 2025-01-17 |
| Boston Scientific Corp | 9 | 2012-08-17 |
| Olympus Medical Systems Corp. | 7 | 2025-10-17 |
| Boston Scientific Corporation | 7 | 2025-06-11 |
| Aqua Medical, Inc. | 5 | 2025-08-08 |
87 more applicants have KNS clearances. See the full list in Caduvo.
Most recent KNS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K262460 | Boston Scientific | Rezum System | 2026-09-03 | 48 |
| K260962 | Taewoong Medical Co., Ltd. | Sphincterotome | 2026-05-21 | 59 |
| K252388 | Francis Medical, Inc. | Vanquish Water Vapor Ablation Device | 2025-11-26 | 118 |
| K252889 | Olympus Medical Systems Corporation | Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M) | 2025-11-25 | 76 |
| K250945 | Olympus Medical Systems Corp. | Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series) | 2025-10-17 | 203 |
Recalls for KNS devices
125 product recalls in 25 recall events; 93 initiated in the last five years and 93 still open. Most recent: 2026-08-19.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2019 | 1 |
| 2021 | 41 |
| 2023 | 1 |
| 2024 | 20 |
| 2025 | 7 |
| 2026 | 34 |
Frequently asked questions
What is FDA product code KNS?
KNS is the FDA product code for unit, electrosurgical, endoscopic (with or without accessories). It is a Class II device, regulated under 21 CFR 876.4300 and reviewed by the Gastroenterology and Urology panel.
What device class is KNS?
Class II, regulation 21 CFR 876.4300. Typical premarket route: 510(k).
How long does a 510(k) take for product code KNS?
Across 189 cleared submissions the average was 106 days from receipt to decision (median 78).
Which companies have the most KNS clearances?
Wilson-Cook Medical, Inc. (11); Boston Scientific Corp (9); Olympus Medical Systems Corp. (7); Boston Scientific Corporation (7); Aqua Medical, Inc. (5).
Have KNS devices been recalled?
Yes: 125 product recalls across 25 recall events; the most recent began 2026-08-19.
Next steps
- Run an FDA pathway report with predicate devices for product code KNS
- Run a recall and safety report across every KNS manufacturer
- Watch product code KNS 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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