Interject Injection Therapy Needle Catheter— 510(k) K171454
Substantially EquivalentBoston Scientific Corporation
FDA 510(k) clearance K171454 for Interject Injection Therapy Needle Catheter, Substantially Equivalent on 2017-07-07. Applicant: Boston Scientific Corporation. Device class: 2.
Clearance details
- Applicant
- Boston Scientific Corporation
- Product code
- Code FBK
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Marlboro, MA, US
Recent devices under product code FBK
view allMore clearances from Boston Scientific Corporation
view allAdverse events under product code FBK
product code FBK- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K171454
K-number listed on FDA's recall record- Z-0225-2023 — ORISE Gel Syringe Submucosal Lifting Agent Kits: indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early-stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or other suitable endoscopic device UPN: (1)Twin Pack Box 1 M00519210; (2)Twin Pack Box 10 M00519211; (3)Single Pack Box 10 M00519231
- Z-0226-2023 — ORISE ProKnife Procedure Kits: indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or other suitable endoscopic device. UPN (1)ORISE ProKnife 1.5 mm Electrode - Kit M00519380; (2) ORISE ProKnife 2.0 mm Electrode - Kit M00519390; (3) ORISE ProKnife 3.0 mm Electrode - Kit M00519400
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K171454.
Data sourced from openFDA. This site is unofficial and independent of the FDA.