510(k) K152771 ยท KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long
| Applicant | Sumitomo Bakelite Co., Ltd., Tokyo, JP |
| Decision | Substantially Equivalent, Jun 17, 2016 |
| Received | Sep 25, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152771
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 9, 2016 | Akita Sumitomo Bakelite Co., Ltd. SB Knife -Electrosurgical Knife, Sterile
Size: Working Length 2.3M Maximum OD 2.6mm.
Product Usage:
The SB Knife is a single-use sterile Electrosurgical Knife (Model Numbers: MD-47703W, MD-47704, M Terminated |
KNS | None listed |
| Sep 9, 2016 | Akita Sumitomo Bakelite Co., Ltd. SB (Sumitomo Bakelite Co.,) Electrosurgical Knife
Size: Working Length 1.8M Maximum OD 2.6mm.
Product Usage:
The SB Knife is a single-use sterile Electrosurgical Knife (Model Numbers: MD-47703W, MD- Terminated |
KNS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.