SAFE CONNECT SURGICAL CABLE (S-101-97/S-201-97/FL-601-97)— 510(k) K971968
Substantially EquivalentRemington Medical, Inc.
FDA 510(k) clearance K971968 for SAFE CONNECT SURGICAL CABLE (S-101-97/S-201-97/FL-601-97), Substantially Equivalent on 1997-07-23. Applicant: Remington Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Remington Medical, Inc.
- Product code
- Code DSA
- Device class
- Class 2
- Regulation
- 21 CFR 870.2900
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Alpharetta, GA, US
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Adverse events under product code DSA
product code DSA- Death
- 2
- Total
- 2
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 K971968
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 K971968.
Data sourced from openFDA. This site is unofficial and independent of the FDA.