SCOTTS SURGICAL RETRACTOR AND ELASTIC— 510(k) K791665
Substantially EquivalentLone Star Medical Products, Inc.
FDA 510(k) clearance K791665 for SCOTTS SURGICAL RETRACTOR AND ELASTIC, Substantially Equivalent on 1979-09-19. Applicant: Lone Star Medical Products, Inc.. Device class: 1.
Clearance details
- Applicant
- Lone Star Medical Products, Inc.
- Product code
- Code GAD
- Device class
- Class 1
- Regulation
- 21 CFR 878.4800
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code GAD
view allMore clearances from Lone Star Medical Products, Inc.
view allAdverse events under product code GAD
product code GAD- Malfunction
- 504
- Total
- 504
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 K791665
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 K791665.
Data sourced from openFDA. This site is unofficial and independent of the FDA.