ARTHOCARE ARTHROSCOPIC ELECTROSURGERY SYSTEM MODEL 970— 510(k) K962321
Substantially EquivalentArthrocare Corp.
FDA 510(k) clearance K962321 for ARTHOCARE ARTHROSCOPIC ELECTROSURGERY SYSTEM MODEL 970, Substantially Equivalent on 1996-07-19. Applicant: Arthrocare Corp.. Device class: 2.
Clearance details
- Applicant
- Arthrocare Corp.
- Product code
- Code HRX
- Device class
- Class 2
- Regulation
- 21 CFR 888.1100
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sunnyvale, CA, US
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- K111397 — TITAN TI SUTURE ANCHOR SYSTEM
Adverse events under product code HRX
product code HRX- Injury
- 623
- Malfunction
- 11,257
- Total
- 11,880
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.