FDA product code KNF: Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
KNF is the FDA product code for coagulator-cutter, endoscopic, unipolar (and accessories). It is a Class II device, regulated under 21 CFR 884.4160 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 44 510(k) submissions under KNF, 4 in the last five years, from 30 different applicants. The average 510(k) review took 187 days (median 130); 85 days on average over the last three years. FDA has posted 5 recalls for KNF devices.
Classification
| Field | Value |
|---|---|
| Device name | Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) |
| Device class | Class II |
| Regulation | 21 CFR 884.4160 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for KNF
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 254 |
| 2020 | 1 | 137 |
| 2021 | 1 | 30 |
| 2022 | 1 | 99 |
| 2023 | 1 | 16 |
| 2024 | 1 | 147 |
| 2025 | 1 | 23 |
Compare with all 510(k) review times · Search every KNF clearance
Top KNF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Gynesonics, Inc. | 7 | 2025-04-02 |
| KARL STORZ Endoscopy-America, Inc. | 4 | 1995-02-09 |
| Kli | 3 | 1978-06-22 |
| Lina Medical Aps | 2 | 2014-01-31 |
| Omnitech Systems, Inc. | 2 | 1998-07-17 |
25 more applicants have KNF clearances. See the full list in Caduvo.
Most recent KNF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K250705 | Gynesonics, Inc. | Sonata Transcervical Fibroid Ablation System 2.2 | 2025-04-02 | 23 |
| K240503 | Gynesonics, Inc. | Sonata Transcervical Fibroid Ablation System 2.2 | 2024-07-17 | 147 |
| K233848 | Gynesonics, Inc. | Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220) | 2023-12-21 | 16 |
| K222304 | Gynesonics, Inc. | Sonata Transcervical Fibroid Ablation System 2.2 | 2022-11-08 | 99 |
| K211535 | Gynesonics, Inc. | Sonata Transcervical Fibroid Ablation System 2.2 | 2021-06-17 | 30 |
Recalls for KNF devices
5 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2013-02-12.
Frequently asked questions
What is FDA product code KNF?
KNF is the FDA product code for coagulator-cutter, endoscopic, unipolar (and accessories). It is a Class II device, regulated under 21 CFR 884.4160 and reviewed by the Obstetrics and Gynecology panel.
What device class is KNF?
Class II, regulation 21 CFR 884.4160. Typical premarket route: 510(k).
How long does a 510(k) take for product code KNF?
Across 44 cleared submissions the average was 187 days from receipt to decision (median 130).
Which companies have the most KNF clearances?
Gynesonics, Inc. (7); KARL STORZ Endoscopy-America, Inc. (4); Kli (3); Lina Medical Aps (2); Omnitech Systems, Inc. (2).
Have KNF devices been recalled?
Yes: 5 product recalls across 3 recall events; the most recent began 2013-02-12.
Next steps
- Run an FDA pathway report with predicate devices for product code KNF
- Run a recall and safety report across every KNF manufacturer
- Watch product code KNF 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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