Drill, Surgical, Ent (Electric or Pneumatic) Including Handpiece
3.5 mm ENT Precision Cutter Angle Agg. Serr 40 Degree ESSx/HUMMER 4 11.0 cm Working Length
2manufacturers in China registered for this device type
87catalogue numbers in this listing
8510(k) clearances naming this product code
4recalls on this code
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 | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | ERL |
| Device type | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece |
| Device class | Class 2 |
| Regulation | 21 CFR 874.4250 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2016-09-23 |
| Record revised | 2019-11-07 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment atmospheric pressure 50 to 106 KiloPascal; Storage environment humidity 10 to 75 % RH; Storage environment temperature -20 to 40 °C |
| Packaging | Pack of 5, pack of 3 |
| Sizes | Length 4 to 11 cm; angle 12 to 60 °; length 3 to 25 mm |
| Distribution end date | 2021-09-16 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5407100000 | In distribution | |
| 5290440100 | Angle 40.0 ° | In distribution |
| 5100120922 | In distribution | |
| 5290435100 | Length 11.0 cm | In distribution |
| 5100120492 | In distribution | |
| 5100010060S2 | In distribution | |
| 5290011000 | Diameter: 4.0 Millimeter | In distribution |
| 5290740200 | Angle 40.0 ° | In distribution |
| 5290530000 | Diameter: 3.5 Millimeter | In distribution |
| 2296301000 | In distribution | |
| 5100120450 | In distribution | |
| 5100010480 | In distribution | |
| 5100010248 | Length 16.0 mm | In distribution |
| 5100010210 | In distribution | |
| 5407010200 | Length 9.0 cm | In distribution |
| 5100120490 | In distribution | |
| 5290760100 | Angle 60.0 ° | In distribution |
| 5100010301 | In distribution | |
| 5407-300-100 | In distribution | |
| 5100010049 | Diameter: 25.0 Millimeter | In distribution |
| 5100010470 | In distribution | |
| 5100010301S2 | Length 7.0 mm | In distribution |
| 5100120452 | In distribution | |
| 5450040013 | Length 4.0 cm | In distribution |
| 5100010278 | In distribution | |
| 5450040000 | Length 4.0 cm | In distribution |
| 5400001030 | In distribution | |
| 5400121000S1 | In distribution | |
| 5290638000 | Diameter: 3.5 Millimeter | In distribution |
| 5450040002 | Length 4.0 cm | In distribution |
| 5100120485 | In distribution | |
| 5290635100 | Length 11.0 cm | In distribution |
| 5407521008 | Length 8.0 cm | In distribution |
| 5450040003 | Length 4.0 cm | In distribution |
| 5100120920 | In distribution | |
| 5100010200 | In distribution | |
| 5100010272 | In distribution | |
| 5407-300-000 | In distribution | |
| 5290647000 | Diameter: 3.0 Millimeter | In distribution |
| 5290640100 | Diameter: 4.0 Millimeter | In distribution |
| 5450400000 | In distribution | |
| 5290635000 | Diameter: 3.5 Millimeter | In distribution |
| 5100120482 | In distribution | |
| 2296302000 | In distribution | |
| 5100120952 | In distribution | |
| 5450040001 | Length 4.0 cm | In distribution |
| 5290740100 | Diameter: 4.0 Millimeter | In distribution |
| 5100120480 | In distribution | |
| 5400121000 | In distribution | |
| 5100010302 | In distribution | |
| 5290628000 | Diameter: 2.5 Millimeter | In distribution |
| 5450040011 | Length 4.0 cm | In distribution |
| 5100010450 | In distribution | |
| 5100010247 | Length 12.0 mm | In distribution |
| 5100120470 | In distribution | |
| 5100120045 | In distribution | |
| 5290645000 | Diameter: 4.0 Millimeter | In distribution |
| 5100010270 | In distribution | |
| 5290540000 | Length 8.0 cm | In distribution |
| 5100120472 | In distribution | |
| 5100010301S1 | Length 3.0 mm | In distribution |
| 5100010249 | Length 25.0 mm | In distribution |
| 5290744100 | Diameter: 4.0 Millimeter | In distribution |
| 5100010048 | Diameter: 16.0 Millimeter | In distribution |
| 5290340000 | Diameter: 4.0 Millimeter | In distribution |
| 5290648000 | Length 8.0 cm | In distribution |
| 5100010022 | Withdrawn | |
| 5100010950 | Withdrawn | |
| 5100010072 | Withdrawn | |
| 5100010490 | Withdrawn | |
| 5100120044 | Withdrawn | |
| 5100010482S1 | Withdrawn | |
| 5100010090 | Withdrawn | |
| 5100010920 | Withdrawn | |
| 5100010501 | Withdrawn | |
| 5100010922 | Withdrawn | |
| 5100010052 | Withdrawn | |
| 5100010952 | Withdrawn | |
| 5100010050 | Withdrawn | |
| 5100010070 | Withdrawn | |
| 5100010020 | Withdrawn | |
| 5100010080 | Withdrawn | |
| 5100010452 | Withdrawn | |
| 5100010011 | Withdrawn | |
| 5100010472 | Withdrawn | |
| 5100010482 | Withdrawn | |
| 5100120950 | Withdrawn |
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 |
| Midas REX Microsaws | Medtronic Powered Surgical Solutions | 75 |
| Piezomed Pro Accessory | W&H Dentalwerk Bürmoos GmbH | 50 |
| Midas Rex Clearview™ | Medtronic Xomed, Inc. | 47 |
| Zethon | Zethon Ltd | 39 |
| 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 |
|---|---|
| K211490 | 2021-06-09 |
| K171840 | 2017-09-15 |
| K152641 | 2015-11-20 |
| K141935 | 2014-09-26 |
| K112593 | 2012-05-01 |
| K080052 | 2008-10-02 |
| K943569 | 1995-01-09 |
| K940710 | 1994-05-16 |
Recalls
4 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2014-03-18 | Class II | Employee error | Stryker Instruments is voluntarily recalling the single use 2.5MM Aggressive Blade because the line on the affected part (P/N 5290-928-000, Lot #13280CG2) was a straight line without a number scale or logo. The line required for this part n | 90 units | 2014-05-15 |
| 2013-07-01 | Class II | Process change control | The safety margin values detailed in the Engineering Design were entered incorrectly into the programming software. Handpieces that have been programmed with the incorrect parameters could result in unintended activation. There is a poten | 0 | 2013-09-16 |
| 2013-07-01 | Class II | Process change control | The safety margin values detailed in the Engineering Design were entered incorrectly into the programming software. Handpieces that have been programmed with the incorrect parameters could result in unintended activation. There is a poten | 9 | 2013-09-16 |
| 2013-07-01 | Class II | Process change control | The safety margin values detailed in the Engineering Design were entered incorrectly into the programming software. Handpieces that have been programmed with the incorrect parameters could result in unintended activation. There is a poten | 11 | 2013-09-16 |
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.