FDA product code LRC: Instrument, Ent Manual Surgical
LRC is the FDA product code for instrument, ent manual surgical. It is a Class I device, regulated under 21 CFR 874.4420 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 65 510(k) submissions under LRC, 2 in the last five years, from 24 different applicants. The average 510(k) review took 102 days (median 85). FDA has posted 5 recalls for LRC devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Instrument, Ent Manual Surgical |
| Device class | Class I |
| Regulation | 21 CFR 874.4420 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) exempt |
510(k) clearances per year for LRC
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 91 |
| 2018 | 1 | 163 |
| 2019 | 1 | 60 |
| 2020 | 4 | 229 |
| 2022 | 1 | 156 |
| 2023 | 1 | 114 |
Compare with all 510(k) review times · Search every LRC clearance
Top LRC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Entellus Medical, Inc. | 21 | 2015-11-20 |
| Acclarent, Inc. | 13 | 2020-08-27 |
| Exmoor Plastics , Ltd. | 5 | 1999-03-05 |
| United States Surgical, A Division of Tyco Healthc | 3 | 1994-06-08 |
| Intuit Medical Products, LLC | 2 | 2020-01-03 |
19 more applicants have LRC clearances. See the full list in Caduvo.
Most recent LRC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K230258 | Excelent, Inc. | BB 8 Sinus Dilation Kit | 2023-05-25 | 114 |
| K212774 | Intersect Ent. | VenSure LightGuide | 2022-02-04 | 156 |
| K201398 | Stryker Ent | SINUSPRIME Dilation System | 2020-10-15 | 140 |
| K201115 | Acclarent, Inc. | Next Generation Balloon Dilation System | 2020-08-27 | 122 |
| K201472 | Fiagon GmbH | VenSure Balloon Device, VenSure Nav Balloon Device | 2020-08-26 | 84 |
Recalls for LRC devices
5 product recalls in 5 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2024-12-19.
| Year | Recalls |
|---|---|
| 2023 | 1 |
| 2024 | 2 |
Frequently asked questions
What is FDA product code LRC?
LRC is the FDA product code for instrument, ent manual surgical. It is a Class I device, regulated under 21 CFR 874.4420 and reviewed by the Ear, Nose and Throat panel.
What device class is LRC?
Class I, regulation 21 CFR 874.4420. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LRC?
Across 65 cleared submissions the average was 102 days from receipt to decision (median 85).
Which companies have the most LRC clearances?
Entellus Medical, Inc. (21); Acclarent, Inc. (13); Exmoor Plastics , Ltd. (5); United States Surgical, A Division of Tyco Healthc (3); Intuit Medical Products, LLC (2).
Have LRC devices been recalled?
Yes: 5 product recalls across 5 recall events; the most recent began 2024-12-19.
Next steps
- Run an FDA pathway report with predicate devices for product code LRC
- Run a recall and safety report across every LRC manufacturer
- Watch product code LRC 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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