Panels › Ear, Nose, Throat › Product code LRC · Class 1
Instrument, Ent Manual Surgical
Regulation 874.4420
0510(k)s in 12 months (65 all time)
0recalls in 12 months (5 all time)
0recalls that name a 510(k)
Top companies in LRC
| Company | 510(k)s | Recalls |
|---|---|---|
| Entellus Medical, Inc. | 21 | 0 |
| Acclarent, Inc. | 13 | 1 |
| Exmoor Plastics , Ltd. | 5 | 0 |
| Karl Storz Endoscopy | 0 | 3 |
| United States Surgical, A Division of Tyco Healthc | 3 | 0 |
| Intuit Medical Products, LLC | 2 | 0 |
| Medtronic Xomed, Inc. | 2 | 0 |
| Sinusys Corporation | 2 | 0 |
| 3nt Medical , Ltd. | 1 | 0 |
| Arthrocare Corp. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 10, 2025 | Karl Storz Endoscopy Karl Storz - Endoskope - REF 723400 - Optical Biopsy and Grasping Forceps, CE Open, Classified |
LRC | None listed |
| Apr 3, 2024 | Karl Storz Endoscopy Karl Storz SE & CO. KG, REF 723014, Uvula Retractor, For Veterinary Use Only, Rx Only Open, Classified |
LRC | None listed |
| Dec 18, 2023 | Karl Storz Endoscopy Injection Needle, single cvd. 70 degrees, REF: 738750; Injection Needle, single cvd. 80 degrees, REF: 738752; Injection Needle, bayonet, 13 cm, REF: 738756; Injection Needle, angular, 13 cm, REF: 7387 Open, Classified |
LRC | None listed |
| May 31, 2013 | Gyrus Acmi, Incorporated GYRUS ACMI, MYRINGOTOMY KNIFE DISPOSABLE, SICKLE BLADE FLAT HANDLE, REF 130715, Rx only, STERILE EO, GYRUS ACMI, INC., 136 TURNPIKE ROAD, SOUTHBOROUGH, MA 01722-2104
Disposable myringotomy knife int Terminated |
LRC | None listed |
| Feb 24, 2006 | Acclarent Inc Acclarent brand Relieva Sinus Inflation Device Kit;
Model BID30; The kit contains 1 inflation device, 1-10'' extension tube, 1-20cc syringe, 3-way stop-cock; Manufactured for Acclarent, Inc., 1525-B O Terminated |
LRC | None listed |
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