RANFAC GOLDENBERG SNARECOIL SOFT TISSUE BIOPSY (GSS) NEEDLE— 510(k) K031344
Substantially EquivalentRanfac, Corp.
FDA 510(k) clearance K031344 for RANFAC GOLDENBERG SNARECOIL SOFT TISSUE BIOPSY (GSS) NEEDLE, Substantially Equivalent on 2003-05-23. Applicant: Ranfac, Corp.. Device class: 2.
Clearance details
- Applicant
- Ranfac, Corp.
- Product code
- Code KNW
- Device class
- Class 2
- Regulation
- 21 CFR 876.1075
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Foster, RI, US
Recent devices under product code KNW
view allMore clearances from Ranfac, Corp.
view all- K162932 — Ranfac Fat Aspiration Cannula
- K150156 — Ranfac Fat Aspiration Transfer Syringe (FATS) Procedure Pack, Ranfac Fat Aspiration Transfer Syringe (FATS) Containment Vessel
- K150563 — Marrow Cellution Bone Marrow Aspiration Needle
- K140991 — RANFAC ASPIRATION NEEDLE WITH ADJUSTABLE GUIDE
- K131157 — RANFAC BONE MARROW ASPIRATION NEEDLE
Adverse events under product code KNW
product code KNW- Death
- 9
- Injury
- 965
- Malfunction
- 10,444
- Other
- 3
- Total
- 11,421
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.