Zethon
S-C18S - 180MM Straight Slimline Attachment (2.38MM)
2manufacturers in China registered for this device type
39catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Shanghai (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jabil Circuit (Shanghai) Ltd. | Shanghai | Shanghai | Contract manufacturer | 31 |
| Guangdong Jinme Medical Technology Co., Ltd. | Foshan | Guangdong | Manufacturer | 13 |
Record
| Listed by | Zethon Ltd, United Kingdom |
|---|---|
| FDA product code | ERL |
| Device type | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece |
| Device class | Class 2 |
| Regulation | 21 CFR 874.4250 |
| Establishment | Manufacturer |
| 510(k) | K233958 |
| Record published | 2025-10-22 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 103371 | In distribution | |
| 103472 | In distribution | |
| 104320 | In distribution | |
| 103519 | In distribution | |
| 104137 | In distribution | |
| 104070 | In distribution | |
| 103383 | In distribution | |
| 104035 | In distribution | |
| 103352 | In distribution | |
| 104432 | In distribution | |
| 104429 | In distribution | |
| 103438 | In distribution | |
| 103495 | In distribution | |
| 103305 | In distribution | |
| 103318 | In distribution | |
| 103347 | In distribution | |
| 103409 | In distribution | |
| 103480 | In distribution | |
| 104312 | In distribution | |
| 104081 | In distribution | |
| 103508 | In distribution | |
| 103524 | In distribution | |
| 103562 | In distribution | |
| 104159 | In distribution | |
| 104184 | In distribution | |
| 103451 | In distribution | |
| 103446 | In distribution | |
| 104062 | In distribution | |
| 104056 | In distribution | |
| 103360 | In distribution | |
| 103339 | In distribution | |
| 104100 | In distribution | |
| 103556 | In distribution | |
| 103394 | In distribution | |
| 103581 | In distribution | |
| 104097 | In distribution | |
| 103467 | In distribution | |
| 104043 | In distribution | |
| 103414 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ENT MR8 | Medtronic Powered Surgical Solutions | 234 |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | Anspach Effort, The | 214 |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | Karl Storz GmbH & Co. KG | 208 |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | Synthes Gmbh | 126 |
| Midas Rex | Medtronic Powered Surgical Solutions | 97 |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | Stryker GmbH | 87 |
| Midas REX Microsaws | Medtronic Powered Surgical Solutions | 75 |
| Piezomed Pro Accessory | W&H Dentalwerk Bürmoos GmbH | 50 |
| Midas Rex Clearview™ | Medtronic Xomed, Inc. | 47 |
| NSK Sterile Burs/Drills | Nakanishi Inc. | 34 |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | Medtronic Xomed, Inc. | 29 |
| Core | Stryker GmbH | 27 |
Showing 12 of 169. All products under Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K233958 | 2024-03-14 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.