SAFE CONNECT SURGICAL CABLE (S-101-97/S-201-97/FL-601-97)— 510(k) K971968

Substantially Equivalent

Remington 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..

Clearance details

Applicant: Remington Medical, Inc.
Product code: Code DSA
Advisory panel: Cardiovascular
Date received: 1997-05-28
Decision date: 1997-07-23
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, 2020-01-01 through 2026-04-23. 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.