Pilling
Cushing BAY FCP Bipol 7.5"INS XF TIP 0.7
65manufacturers in China registered for this device type
140catalogue numbers in this listing
12recalls 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 | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | GEI |
| Device type | Electrosurgical, Cutting & Coagulation & Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4400 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K771752 |
| Record published | 2020-04-23 |
| Record revised | 2026-02-06 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date, serial number |
| Sizes | Length 5.125 to 21.26 in; length 411 to 485 mm; length 10 ft |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPN009574 | In distribution | |
| IPN009620 | In distribution | |
| IPN005498 | Length 5.125 in | In distribution |
| IPN009577 | In distribution | |
| IPN009588 | In distribution | |
| IPN009573 | In distribution | |
| IPN009526 | In distribution | |
| IPN007958 | Length 10 ft | In distribution |
| IPN007957 | Length 11.5 in | In distribution |
| IPN009629 | In distribution | |
| IPN017550 | In distribution | |
| IPN009640 | In distribution | |
| IPN009627 | In distribution | |
| IPN926816 | In distribution | |
| IPN009581 | In distribution | |
| IPN009603 | In distribution | |
| IPN021318 | In distribution | |
| IPN009551 | In distribution | |
| IPN009595 | In distribution | |
| IPN009512 | In distribution | |
| IPN911995 | In distribution | |
| IPN009553 | In distribution | |
| IPN021319 | In distribution | |
| IPN009608 | In distribution | |
| IPN926638 | In distribution | |
| IPN021336 | In distribution | |
| IPN009548 | In distribution | |
| IPN022309 | In distribution | |
| IPN009603 | In distribution | |
| IPN009608 | In distribution | |
| IPN009524 | In distribution | |
| IPN021321 | In distribution | |
| IPN021347 | In distribution | |
| IPN021317 | In distribution | |
| IPN009528 | In distribution | |
| IPN009506 | In distribution | |
| IPN009605 | In distribution | |
| IPN009517 | In distribution | |
| IPN009621 | In distribution | |
| IPN926627 | In distribution | |
| IPN009582 | In distribution | |
| IPN926637 | In distribution | |
| IPN009671 | In distribution | |
| IPN009622 | In distribution | |
| IPN021324 | In distribution | |
| IPN009503 | In distribution | |
| IPN926636 | In distribution | |
| IPN009630 | In distribution | |
| IPN009621 | In distribution | |
| IPN926813 | In distribution | |
| IPN009578 | In distribution | |
| IPN017533 | In distribution | |
| IPN907059 | In distribution | |
| IPN009667 | In distribution | |
| IPN009645 | In distribution | |
| IPN009568 | In distribution | |
| IPN021333 | In distribution | |
| IPN009525 | In distribution | |
| IPN009587 | In distribution | |
| IPN009509 | In distribution | |
| IPN926625 | In distribution | |
| IPN009589 | In distribution | |
| IPN009511 | Length 485 mm | In distribution |
| IPN009661 | In distribution | |
| IPN022289 | In distribution | |
| IPN009576 | In distribution | |
| IPN928912 | In distribution | |
| IPN009564 | In distribution | |
| IPN009549 | In distribution | |
| IPN009626 | In distribution | |
| IPN009586 | In distribution | |
| IPN009579 | In distribution | |
| IPN009643 | In distribution | |
| IPN009560 | In distribution | |
| IPN009668 | In distribution | |
| IPN021332 | In distribution | |
| IPN009522 | In distribution | |
| IPN009567 | In distribution | |
| IPN022309 | In distribution | |
| IPN021317 | In distribution | |
| IPN021321 | In distribution | |
| IPN009606 | In distribution | |
| IPN009606 | In distribution | |
| IPN022393 | In distribution | |
| IPN009624 | In distribution | |
| IPN022549 | In distribution | |
| IPN927412 | In distribution | |
| IPN022773 | In distribution | |
| IPN021347 | In distribution | |
| IPN009519 | In distribution | |
| IPN021355 | In distribution | |
| IPN009585 | In distribution | |
| IPN009505 | In distribution | |
| IPN017548 | In distribution | |
| IPN007959 | Length 21.26 in | In distribution |
| IPN022393 | In distribution | |
| IPN021348 | In distribution | |
| IPN021318 | In distribution | |
| IPN009596 | In distribution | |
| IPN009527 | In distribution | |
| IPN009620 | In distribution | |
| IPN009556 | In distribution | |
| IPN009563 | In distribution | |
| IPN009601 | In distribution | |
| IPN009555 | In distribution | |
| IPN021319 | In distribution | |
| IPN009595 | In distribution | |
| IPN009533 | In distribution | |
| IPN009599 | In distribution | |
| IPN009664 | In distribution | |
| IPN021324 | In distribution | |
| IPN009627 | In distribution | |
| IPN009669 | Length 411 mm | In distribution |
| IPN009550 | In distribution | |
| IPN009513 | In distribution | |
| IPN009644 | In distribution | |
| IPN009673 | In distribution | |
| IPN009518 | In distribution | |
| IPN009572 | In distribution | |
| IPN021335 | In distribution | |
| IPN009511 | Length 485 mm | In distribution |
| IPN009604 | In distribution | |
| IPN926817 | In distribution | |
| IPN009584 | In distribution | |
| IPN009539 | In distribution | |
| IPN009507 | In distribution | |
| IPN009543 | In distribution | |
| IPN009602 | In distribution | |
| IPN021336 | In distribution | |
| IPN056770 | In distribution | |
| IPN926626 | In distribution | |
| IPN009559 | In distribution | |
| IPN009605 | In distribution | |
| IPN009628 | In distribution | |
| IPN009535 | In distribution | |
| IPN021348 | In distribution | |
| IPN009547 | In distribution | |
| IPN009520 | In distribution | |
| IPN009570 | In distribution | |
| IPN021355 | In distribution |
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
Recalls Naming This Product
2 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 |
|---|---|---|---|---|---|---|---|
| Teleflex Medical LLC | 510(k) number | 2013-12-19 | Class II | Nonconforming Material/Component | Sterility cannot be guaranteed. | 17,450 ea. | 2016-05-20 |
| Teleflex Medical LLC | 510(k) number | 2013-12-19 | Class II | Nonconforming Material/Component | Sterility cannot be guaranteed. | 17,450 ea | 2016-05-20 |
Recalls
9 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 |
|---|---|---|---|---|---|
| 2018-01-03 | Class II | Process control | There is potential for a piece of the distal tip on the Percuvance shaft to become deformed and possibly break off during use. If a piece did break off it could compromise the functionality and security of the tool tip. Should this occur du | 1751 units | 2020-10-30 |
| 2018-01-03 | Class II | Process control | There is potential for a piece of the distal tip on the Percuvance shaft to become deformed and possibly break off during use. If a piece did break off it could compromise the functionality and security of the tool tip. Should this occur du | 1962 units | 2020-10-30 |
| 2017-10-18 | Class II | Under Investigation by firm | Teleflex is recalling these products because the jaws of the tool tip may break, causing a fragment of the tool tip to fall off during use. | 3904 units | 2020-10-06 |
| 2017-07-19 | Class II | Device Design | For some of the recalled products, the security of the connection between the shaft and the tool tip may be compromised. For certain other recalled lots of the products, the jaws of the tool tips may close abruptly. | 20,039 total (US and OUS) | 2020-10-06 |
| 2017-07-19 | Class II | Device Design | For some of the recalled products, the security of the connection between the shaft and the tool tip may be compromised. For certain other recalled lots of the products, the jaws of the tool tips may close abruptly. | 20,039 total (US and OUS) | 2020-10-06 |
| 2017-07-19 | Class II | Device Design | For some of the recalled products, the security of the connection between the shaft and the tool tip may be compromised. For certain other recalled lots of the products, the jaws of the tool tips may close abruptly. | 20,039 Total (US and OUS) | 2020-10-06 |
| 2017-07-19 | Class II | Device Design | For some of the recalled products, the security of the connection between the shaft and the tool tip may be compromised. For certain other recalled lots of the products, the jaws of the tool tips may close abruptly. | 20,039 total (US and OUS) | 2020-10-06 |
| 2017-07-19 | Class II | Device Design | For some of the recalled products, the security of the connection between the shaft and the tool tip may be compromised. For certain other recalled lots of the products, the jaws of the tool tips may close abruptly. | 20,039 (US and OUS) | 2020-10-06 |
| 2017-07-19 | Class II | Device Design | For some of the recalled products, the security of the connection between the shaft and the tool tip may be compromised. For certain other recalled lots of the products, the jaws of the tool tips may close abruptly. | 20,039 (US and OUS) | 2020-10-06 |
| 2010-07-30 | Not classified | Other | Complaints were received regarding peeling and melting of the insulation of the cautery tip of the IMA/ENT blade electrodes. | 190,344 eaches | 2011-04-21 |
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.