The following data is part of a premarket notification filed by Ningbo Verykind Medical Device Co., Ltd. with the FDA for Disposable Anorectal Staplers, Disposable Intraluminal Staplers, Disposable Linear Cutting Staplers, Disposable Endoscopic Cutting Staplers.
| Device ID | K211458 |
| 510k Number | K211458 |
| Device Name: | Disposable Anorectal Staplers, Disposable Intraluminal Staplers, Disposable Linear Cutting Staplers, Disposable Endoscopic Cutting Staplers |
| Classification | Staple, Implantable |
| Applicant | Ningbo VeryKind Medical Device Co., Ltd. #100 Jinghua Road, High-tech Industrial Development Zone Ningbo, CN 315040 |
| Contact | Pengfei Hong |
| Correspondent | Diana Hong Mid-Link Consulting Co., Ltd P.O.BOX 120-119 Shanghai, CN 200120 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-11 |
| Decision Date | 2021-12-30 |