ReNew
The filing describes the ReNew XR Handpiece as a detachable instrument for endoscopic procedures, including laparoscopic procedures. Its stated functions include cutting, grasping,…
The filing describes the ReNew XR Handpiece as a detachable instrument for endoscopic procedures, including laparoscopic procedures. Its stated functions include cutting, grasping, dissecting and coagulating tissue.
The submission lists multiple ReNew XR configurations, including different lengths and ratcheted or non-ratcheted designs. The listed ReNew family is therefore described as a handpiece line with configuration options.
Listed Item
ReNew Laparoscopic Microscissor Scissors Tip, Reusable
Configurations
The variant table lists one-piece handpieces in 25, 34 and 42 cm lengths, with ratcheted and non-ratcheted options.
65manufacturers in China registered for this device type
99catalogue numbers in this listing
6510(k) clearances naming this product code
13recalls 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 | Microline Surgical, Inc, United States |
|---|---|
| FDA product code | GEI |
| Device type | Electrosurgical, Cutting & Coagulation & Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4400 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K201884 |
| Record published | 2017-11-13 |
| Record revised | 2021-07-13 (version 3) |
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 |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Packaging | Box of 5 |
| Distribution end date | 2018-10-31 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 6925 | In distribution | ||
| 63-09-00 | In distribution | ||
| 3122 | 10 | In distribution | |
| 3161 | In distribution | ||
| 3121 | In distribution | ||
| 3162 | 10 | In distribution | |
| 3221 | In distribution | ||
| 3944 | In distribution | ||
| 3934 | In distribution | ||
| 3412 | 10 | In distribution | |
| 3152 | 10 | In distribution | |
| 3301 | In distribution | ||
| 6152 | 10 | In distribution | |
| 3505TA | In distribution | ||
| 3910 | 3 | In distribution | |
| 3112 | 10 | In distribution | |
| 3915 | In distribution | ||
| 6162 | 10 | In distribution | |
| 3372 | 10 | In distribution | |
| 3945 | In distribution | ||
| 6902 | In distribution | ||
| 3201 | In distribution | ||
| 3342 | 10 | In distribution | |
| 6924 | In distribution | ||
| 3382 | 10 | In distribution | |
| 3642 | 10 | In distribution | |
| 3202 | 10 | In distribution | |
| 3222 | 10 | In distribution | |
| 3924 | In distribution | ||
| 3281 | In distribution | ||
| 3311 | In distribution | ||
| 3431 | In distribution | ||
| 3514TA | In distribution | ||
| 3151 | In distribution | ||
| 3252 | 10 | In distribution | |
| 3241 | In distribution | ||
| 3142 | 10 | In distribution | |
| 3232 | 10 | In distribution | |
| 3291 | In distribution | ||
| 3302 | 10 | In distribution | |
| 3946 | In distribution | ||
| 3371 | In distribution | ||
| 3914 | In distribution | ||
| 6172 | 10 | In distribution | |
| 3322 | 10 | In distribution | |
| 3471 | In distribution | ||
| 3402 | 10 | In distribution | |
| 3381 | In distribution | ||
| 3652 | 10 | In distribution | |
| 6182 | 10 | In distribution | |
| 3351 | In distribution | ||
| 3352 | 10 | In distribution | |
| 3332 | 10 | In distribution | |
| 3231 | In distribution | ||
| 3312 | 10 | In distribution | |
| 3942 | In distribution | ||
| 3292 | 10 | In distribution | |
| 3271 | In distribution | ||
| 3515TA | In distribution | ||
| 63-08-00 | In distribution | ||
| 3362 | 10 | In distribution | |
| 3941 | In distribution | ||
| 3242 | 10 | In distribution | |
| 3132 | 10 | In distribution | |
| 3411 | In distribution | ||
| 3261 | In distribution | ||
| 3331 | In distribution | ||
| 3632 | 10 | In distribution | |
| 3908 | In distribution | ||
| 3361 | In distribution | ||
| 3943 | In distribution | ||
| 3935 | In distribution | ||
| 3909 | 3 | In distribution | |
| 3141 | In distribution | ||
| 3904 | In distribution | ||
| 3321 | In distribution | ||
| 3272 | 10 | In distribution | |
| 3251 | In distribution | ||
| 3905 | In distribution | ||
| 3925 | In distribution | ||
| 3622 | 10 | In distribution | |
| 3918 | In distribution | ||
| 3111 | In distribution | ||
| 3504TA | In distribution | ||
| 3472 | 10 | In distribution | |
| 3262 | 10 | In distribution | |
| 3341 | In distribution | ||
| 3401 | In distribution | ||
| 3421 | In distribution | ||
| 3904R | Withdrawn | ||
| 3934R | Withdrawn | ||
| 3918R | Withdrawn | ||
| 3914R | Withdrawn | ||
| 3915R | Withdrawn | ||
| 3925R | Withdrawn | ||
| 3908R | Withdrawn | ||
| 3924R | Withdrawn | ||
| 3905R | Withdrawn | ||
| 3935R | 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 |
|---|---|
| K234147 | 2024-04-23 |
| K213127 | 2022-03-02 |
| K201884 | 2020-10-21 |
| K160706 | 2016-10-19 |
| K124029 | 2013-03-27 |
| K122086 | 2012-08-23 |
Recalls Naming This Product
3 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Microline Surgical, Inc | UDI-DI | 2017-11-01 | Class II | Process control | Certain lots of disposable laparoscopic instrument tips may potentially have a compromised sterile barrier. | 12 box of 10 tips each | 2019-09-17 |
| Microline Surgical, Inc | UDI-DI | 2017-11-01 | Class II | Process control | Certain lots of disposable laparoscopic instrument tips may potentially have a compromised sterile barrier. | 4 boxes of 10 tips each | 2019-09-17 |
| Microline Surgical, Inc | UDI-DI | 2017-07-13 | Class II | Device Design | The heat-shrink insulation tube may split during autoclave sterilization/re-sterilization. If a split occurs, the heat-shrink could fall off during a surgical procedure and if cautery is needed, there is a potential for burn due to insulati | 61,769 units | 2020-02-06 |
Recalls
5 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 |
|---|---|---|---|---|---|
| 2024-11-05 | Class II | Under Investigation by firm | A lot of ReNew Microscissor Tips exhibited a 2% rate of failure in terms of the heat shrink breaking off. | 200 units | |
| 2019-03-22 | Class II | Under Investigation by firm | The shears exhibited a high rate of complete or intermittent failure to actuate. As a result, they do not perform their intended function in surgical procedures. | 115 units | 2020-07-30 |
| 2014-05-12 | Class II | Nonconforming Material/Component | Potential for the Fenestrated Grasper Tip jaw to break when force is applied to the jaw | 150 units | 2015-08-13 |
| 2014-05-12 | Class II | Nonconforming Material/Component | Potential for the Fenestrated Grasper Tip jaw to break when force is applied to the jaw | 6290 units | 2015-08-13 |
| 2014-04-14 | Class II | Nonconforming Material/Component | Grasper jaw may break when force is applied to the jaw | 540 units | 2015-09-02 |
| 2011-07-18 | Not classified | Packaging process control | Mislabeled: ReNew product number 3262 (Long Fenestrated Grasper) was packaged and labeled as product number 3642 (Super-Atrau Fenestrated Grasper). ReNew product number 3642 (Super-Atraumatic Fenestrated Grasper) was packaged and labeled a | 300 units | 2011-09-09 |
| 2011-07-18 | Not classified | Packaging process control | Mislabeled: ReNew product number 3262 (Long Fenestrated Grasper) was packaged and labeled as product number 3642 (Super-Atrau Fenestrated Grasper). ReNew product number 3642 (Super-Atraumatic Fenestrated Grasper) was packaged and labeled a | 170 units | 2011-09-09 |
| 2010-03-09 | Not classified | Device Design | The Starion Instruments Thermal Ligating Shears (STLS) 35C and the Starion Thermal Ligating Shears (STLS) 23C may turn on and remain on without the finger button being depressed. The devices may also work intermittently, incorrectly indic | 228 units | 2010-11-27 |
| 2008-06-26 | Not classified | Process control | Due to an improper fixture revision, device may be missing a screw at the jaw assembly, resulting in jaw components falling off during use. | 217 units | 2010-10-27 |
| 2008-02-06 | Not classified | Nonconforming Material/Component | Some jaws exhibited lack of ductility and could break if overloaded or used improperly by placing too much tissue in the bottom of the “v” of the jaw. | 2010-11-27 |
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.