BMC RF CANNULA— 510(k) K972846
Substantially EquivalentBaylis Medical Co., Inc.
FDA 510(k) clearance K972846 for BMC RF CANNULA, Substantially Equivalent on 1998-07-17. Applicant: Baylis Medical Co., Inc.. Device class: 2.
Clearance details
- Applicant
- Baylis Medical Co., Inc.
- Product code
- Code GXI
- Device class
- Class 2
- Regulation
- 21 CFR 882.4725
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mississauga, CA
Recent devices under product code GXI
view allMore clearances from Baylis Medical Co., Inc.
view allAdverse events under product code GXI
product code GXI- Death
- 3
- Injury
- 171
- Total
- 174
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 K972846
K-number listed on FDA's recall record- Z-0850-2014 — Kimberly-Clark RadiOpaque Radiofrequency Cannula, Gauge 22, Length 100 mm, Active Tip 10 mm, Distributed in the US by Kimberly-Clark,Product code PMF22-100-10 The product is used to create lesions in nervous tissue when used with the Kimberly-Clark radiofrequency generator and probes.
- Z-0879-2013 — BMC RF Cannula Curved Sharp RadiOpaque, Non-Pyrogenic, Active Tip: 10mm, Gauge 16 Ga, Length: 100mm. The BMC RF Cannula is sealed in a Tyvek pouch (primary packaging) and then placed into a white shelf-box (secondary packaging) with the instructions for use. A predetermined number of white shelf-boxes are then placed into shipping cartons (tertiary packaging). The BMC RF Cannula is intended for use in radiofrequency heat lesion procedures for relief of pain.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K972846.
Data sourced from openFDA. This site is unofficial and independent of the FDA.