EG1™ High Speed System
20.2 cm Heavy Duty X-Long Attachment, G1
2manufacturers in China registered for this device type
1catalogue number
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 | Synthes 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 | Specification developer, Manufacturer, Exporter |
| 510(k) | K133604 |
| Record published | 2021-05-05 |
| Record revised | 2025-10-01 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Special storage condition: Keep Dry |
| Distribution end date | 2025-10-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| XL-HD-G1 | Withdrawn |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 |
| 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 |
| Zethon | Zethon Ltd | 39 |
| NSK Sterile Burs/Drills | Nakanishi Inc. | 34 |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | Medtronic Xomed, Inc. | 29 |
Showing 12 of 169. All products under Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Recalls Naming This Product
11 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| THE Anspach Effort, Inc. | 510(k) number | 2022-12-07 | Class II | Under Investigation by firm | Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in the | 6059 units in total | |
| THE Anspach Effort, Inc. | 510(k) number | 2022-12-07 | Class II | Under Investigation by firm | Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in the | 6059 units in total | |
| THE Anspach Effort, Inc. | 510(k) number | 2022-12-07 | Class II | Under Investigation by firm | Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in the | 6059 units in total | |
| THE Anspach Effort, Inc. | 510(k) number | 2022-12-07 | Class II | Under Investigation by firm | Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in the | 6059 units in total | |
| THE Anspach Effort, Inc. | 510(k) number | 2022-12-07 | Class II | Under Investigation by firm | Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in the | 6059 units in total | |
| THE Anspach Effort, Inc. | 510(k) number | 2022-12-07 | Class II | Under Investigation by firm | Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in the | 6059 units in total | |
| THE Anspach Effort, Inc. | 510(k) number | 2022-12-07 | Class II | Under Investigation by firm | Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in the | 6059 units in total | |
| THE Anspach Effort, Inc. | 510(k) number | 2022-12-07 | Class II | Under Investigation by firm | Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in the | 6059 units in total | |
| THE Anspach Effort, Inc. | 510(k) number | 2022-12-07 | Class II | Under Investigation by firm | Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in the | 6059 units in total | |
| THE Anspach Effort, Inc. | 510(k) number | 2016-06-15 | Class II | Employee error | The graphics at the attachment interface indicating locked and unlocked position are reversed. | 18 | 2016-12-14 |
| THE Anspach Effort, Inc. | 510(k) number | 2014-12-10 | Class II | Environmental control | Customer complaint indicating the color bands on the MIA16-G1 were not correct. | 8 | 2016-05-09 |
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.