Diego Elite
SHAVER BLADE, 4 MM, 40 DEGREES monopolar distal suction, T/A MALLEABLE, MONOPOLAR DIEGO ELITE
65manufacturers in China registered for this device type
24catalogue numbers in this listing
20510(k) clearances naming this product code
24recalls on this code
Who Else Makes It
Concentrated in Guangdong (24), Zhejiang (13), Shanghai (10). 23 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Hangzhou Kangji Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Hangzhou Endo Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 19 |
| Hong Qiangxing (Shen Zhen) Electronics Limited | Shenzhen | Guangdong | Contract manufacturer | 19 |
| Shenzhen MED-Link Electronics Tech Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 18 |
| Sanbor Medical Xiamen, Inc. | Xiamen | Fujian | Contract manufacturer | 16 |
| ATL Technology DG,Ltd. | Dongguan | Guangdong | Contract manufacturer | 14 |
| Jiangyin Sinbon Electronics Co Ltd | Jiangyin | Jiangsu | Contract manufacturer | 13 |
| Guangzhou Huada Biotechnology Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 9 |
Showing 12 of 65. All 65 manufacturers in China registered for Electrosurgical, Cutting & Coagulation & Accessories
Record
| Listed by | Gyrus Acmi, Inc., United States |
|---|---|
| FDA product code | GEI |
| Device type | Electrosurgical, Cutting & Coagulation & Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4400 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K123429 |
| Record published | 2016-10-05 |
| Record revised | 2024-09-02 (version 9) |
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 temperature 25 to 60 °C; Storage environment humidity 10 to 85 % RH; Storage environment atmospheric pressure 50 to 106 KiloPascal |
| Packaging | Pack of 5 |
| Distribution end date | 2026-03-26 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MDHP100S | In distribution | |
| NCGRIP | In distribution | |
| TS102SF | In distribution | |
| BB4000SC | In distribution | |
| TS100S | In distribution | |
| MDFS100 | In distribution | |
| BB2000SA | In distribution | |
| BB4040XC | In distribution | |
| BEMTS101DC | In distribution | |
| MS4000SC | In distribution | |
| BB4000SS | In distribution | |
| MDHPTRAY | In distribution | |
| MB4000SS | In distribution | |
| MDSM220V | In distribution | |
| BB4040XS | In distribution | |
| MDCONS100 | In distribution | |
| MDSM110V | In distribution | |
| BB4040SS | In distribution | |
| MM4000SS | In distribution | |
| MDHP100A | In distribution | |
| BB4040SC | In distribution | |
| TS101DC | In distribution | |
| MB4000SC | Withdrawn | |
| MM4000SC | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Surgical Direct | Surgical Direct, Inc. | 5,729 |
| Speedlock | National Advanced Endoscopy Devices, Inc. | 5,212 |
| Stingray Surgical Products | Stingray Surgical Products L.L.C. | 4,647 |
| Kirwan | Kirwan Surgical Products, LLC. | 1,901 |
| Millennium | Avalign Technologies, Inc. | 1,779 |
| DANmed | Dannoritzer Medizintechnik GmbH & Co. KG | 1,590 |
| Elmed | Elmed, Inc. | 1,519 |
| Symmetry Olsen | Aspen Surgical Products, Inc. | 1,219 |
| Guenter Bissinger Medizintechnik GmbH | Günter Bissinger Medizintechnik GmbH | 1,117 |
| Ambler Surgical | Ambler Surgical, LLC | 756 |
| V. Mueller | Steris Corporation | 661 |
| Aesculap | Aesculap AG | 544 |
Showing 12 of 2,922. All products under Electrosurgical, Cutting & Coagulation & Accessories
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K252487 | 2026-03-02 |
| K231327 | 2023-10-25 |
| K213831 | 2022-01-04 |
| K170908 | 2017-05-19 |
| K163373 | 2016-12-12 |
| K161038 | 2016-10-07 |
| K161825 | 2016-09-26 |
| K152219 | 2015-12-17 |
| K142759 | 2015-01-13 |
| K142350 | 2015-01-08 |
| K142289 | 2014-12-31 |
| K142154 | 2014-12-19 |
| K123429 | 2013-04-05 |
| K100816 | 2010-07-01 |
| K100896 | 2010-06-17 |
| K080844 | 2009-08-13 |
| K083013 | 2008-12-09 |
| K082054 | 2008-08-06 |
| K081954 | 2008-07-31 |
| K080093 | 2008-05-02 |
Recalls Naming This Product
12 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 |
|---|---|---|---|---|---|---|---|
| Gyrus Acmi, Inc. | 510(k) number | 2019-03-08 | Class II | Software design | Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades | US: 107 consoles, OUS: 157 consoles | 2020-05-08 |
| Gyrus Acmi, Inc. | 510(k) number | 2019-03-08 | Class II | Software design | Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades | 502 OUS | 2020-05-08 |
| Gyrus Acmi, Inc. | 510(k) number | 2019-03-08 | Class II | Software design | Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades | 1333 | 2020-05-08 |
| Gyrus Acmi, Inc. | 510(k) number | 2019-03-08 | Class II | Software design | Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades | 82 | 2020-05-08 |
| Gyrus Acmi, Inc. | 510(k) number | 2019-03-08 | Class II | Software design | Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades | 247 | 2020-05-08 |
| Gyrus Acmi, Inc. | 510(k) number | 2019-03-08 | Class II | Software design | Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades | 13 | 2020-05-08 |
| Gyrus Acmi, Inc. | 510(k) number | 2019-03-08 | Class II | Software design | Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades | 193 | 2020-05-08 |
| Gyrus Acmi, Inc. | 510(k) number | 2019-03-08 | Class II | Software design | Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades | 21 | 2020-05-08 |
| Gyrus Acmi, Inc. | 510(k) number | 2019-03-08 | Class II | Software design | Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades | 318 | 2020-05-08 |
| Gyrus Acmi, Inc. | 510(k) number | 2019-03-08 | Class II | Software design | Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades | 161 | 2020-05-08 |
| Gyrus Acmi, Inc. | 510(k) number | 2015-05-08 | Class II | Under Investigation by firm | Potential lack of sterility assurance. | 12,020 boxes | 2016-05-17 |
| Gyrus Acmi, Inc. | 510(k) number | 2015-05-08 | Class II | Under Investigation by firm | Potential lack of sterility assurance. | 22,250 boxes | 2016-05-17 |
Recalls
2 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 |
|---|---|---|---|---|---|
| 2014-08-27 | Class II | Packaging process control | Due to an anomaly in the packaging process, it is possible that a defective seal could be present that may allow a breach of the package’s sterile barrier and may compromise the sterility of the product. | 5520 US, 40 OUS | 2015-09-15 |
| 2013-07-24 | Class II | Packaging process control | On April 29, 2013 Olympus Surgical Technologies America R&D received results from an accelerated aging study conducted as part of a new market submission. The study found that one of 60 Dissector units that underwent 3 year accelerated ag | 1140 | 2014-06-20 |
| 2010-08-06 | Not classified | Packaging | Lack of sterility assurance due to compromised package seals. | 4244 units | 2012-01-26 |
| 2009-08-18 | Not classified | Environmental control | Gyrus ACMI received complaints of a problem with 3103PK, 3104PK, 3105PK, 915000PK, 915005PK, 915010PK – Gyrus ACMI PKS Seal Open Forceps. The metal shim between the jaws may detach during the procedure and fall into the surgical field. Th | 93,665 total (63,418 US, 30,247 OUS) | 2012-03-06 |
| 2009-08-18 | Not classified | Environmental control | Gyrus ACMI received complaints of a problem with 3103PK, 3104PK, 3105PK, 915000PK, 915005PK, 915010PK – Gyrus ACMI PKS Seal Open Forceps. The metal shim between the jaws may detach during the procedure and fall into the surgical field. Th | 93,665 total (63,418 US, 30,247 OUS) | 2012-03-06 |
| 2009-08-18 | Not classified | Environmental control | Gyrus ACMI received complaints of a problem with 3103PK, 3104PK, 3105PK, 915000PK, 915005PK, 915010PK – Gyrus ACMI PKS Seal Open Forceps. The metal shim between the jaws may detach during the procedure and fall into the surgical field. Th | 93,665 total (63,418 US, 30,247 OUS) | 2012-03-06 |
| 2009-08-18 | Not classified | Environmental control | Gyrus ACMI received complaints of a problem with 3103PK, 3104PK, 3105PK, 915000PK, 915005PK, 915010PK – Gyrus ACMI PKS Seal Open Forceps. The metal shim between the jaws may detach during the procedure and fall into the surgical field. Th | 93,665 total (63,418 US, 30,247 OUS) | 2012-03-06 |
| 2009-08-18 | Not classified | Environmental control | Gyrus ACMI received complaints of a problem with 3103PK, 3104PK, 3105PK, 915000PK, 915005PK, 915010PK – Gyrus ACMI PKS Seal Open Forceps. The metal shim between the jaws may detach during the procedure and fall into the surgical field. Th | 93,665 total (63,418 US, 30,247 OUS) | 2012-03-06 |
| 2009-08-18 | Not classified | Environmental control | Gyrus ACMI received complaints of a problem with 3103PK, 3104PK, 3105PK, 915000PK, 915005PK, 915010PK – Gyrus ACMI PKS Seal Open Forceps. The metal shim between the jaws may detach during the procedure and fall into the surgical field. Th | 93,665 total (63,418 US, 30,247 OUS) | 2012-03-06 |
| 2008-10-01 | Not classified | Process control | Sterility may be compromised | 1340 units | 2012-05-07 |
| 2006-05-15 | Not classified | Other | Gyrus ACMI has identified a product issue wherein their PlasmaSEAL Open Forceps, models 2103PK and 917015PK, may not deliver adequate hemostasis during use. Although Gyrus ACMI has had no reports of serious injury to patient, testing indic | 2971 (2931 domestic, 40 OUS) | 2007-01-12 |
| 2003-12-05 | Not classified | Other | The generator may malfunction when used in close proximity to a monopolar generator. | 14 | 2006-12-28 |
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.