FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INTERJECT INJECTION THERAPY NEEDLE, MODELS 1810, 1811, 1815, 1816, 1820, 1821, 1825, 1826, 1830, 1831, 1835, 1836
K Number: K012864
·
Decision Oct 24, 2001
Classifications
1
FEI Numbers
128
Registration Numbers
128
Same Product Code
132
Applicant Total
432
Review Days
58
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- INTERJECT INJECTION THERAPY NEEDLE, MODELS 1810, 1811, 1815, 1816, 1820, 1821, 1825, 1826, 1830, 1831, 1835, 1836
- K Number
- K012864
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1075
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Boston Scientific Corp
- Date Received
- August 27, 2001
- Decision Date
- October 24, 2001
- Product Code
- FCG
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FCG | Biopsy Needle | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FCG), ordered by most recent decision date.
Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ClearTip FNA and FNB Types
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EchoTip AcuCore EUS Biopsy Needle (ECHO-BX-19)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Precision GI
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ClearTip
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EchoTip® AcuCore Ultrasound Biopsy Needle (ECHO-BX-3-22)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Boston Scientific Corp
| K Number | Device Name | ||
|---|---|---|---|
| K243245 | IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (H7493968435730); IceRod 1.5 CX Straight Needle (H7493968535330) | Oct 18, 2024 | Substantially Equivalent |
| K231328 | LUX-Dx II (M302); LUX-Dx II+ (M312) | Aug 19, 2023 | Substantially Equivalent |
| K152853 | WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis Transhepatic Biliary | Nov 20, 2015 | Substantially Equivalent |
| K150692 | AXIOS Stent with Electrocautery Enhanced Delivery System | Aug 5, 2015 | Substantially Equivalent |
| K150303 | XXL Vascular Balloon Dilatation Catheter | Jun 15, 2015 | Substantially Equivalent |
| K150186 | Chariot Guiding Sheath | Jun 5, 2015 | Substantially Equivalent |
| K150679 | EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector | May 29, 2015 | Unknown |
| K141820 | JAGWIRE HIGH PERFORMANCE GUIDWIRE | Oct 21, 2014 | Substantially Equivalent |
| K141344 | EXPEL NEPHROURETERAL DRAINAGE STENT WITH TWIST-LOC HUB SYSTEM, EXPEL URETERAL DRAINAGE STENT SYSTEM | Oct 17, 2014 | Substantially Equivalent |
| K141335 | EXPEL APD DRAINAGE CATHETER SYSTEM | Oct 17, 2014 | Substantially Equivalent |