CHASE SUCKER— 510(k) K971022
Substantially EquivalentChase Medical, Inc.
FDA 510(k) clearance K971022 for CHASE SUCKER, Substantially Equivalent on 1997-04-17. Applicant: Chase Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Chase Medical, Inc.
- Product code
- Code GCX
- Device class
- Class 2
- Regulation
- 21 CFR 880.6740
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Richardson, TX, US
Recent devices under product code GCX
view allMore clearances from Chase Medical, Inc.
view allAdverse events under product code GCX
product code GCX- Death
- 9
- Malfunction
- 592
- Other
- 2
- Total
- 603
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 K971022
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K971022.
Data sourced from openFDA. This site is unofficial and independent of the FDA.