STYLET SHEATH WITH LOCKING CAP AND REUSABLE BATTERY OPERATED LIGHT SOURCE— 510(k) K944729

Substantially Equivalent

Coast Medical, Inc.

FDA 510(k) clearance K944729 for STYLET SHEATH WITH LOCKING CAP AND REUSABLE BATTERY OPERATED LIGHT SOURCE, Substantially Equivalent on 1994-12-21. Applicant: Coast Medical, Inc..

Clearance details

Applicant: Coast Medical, Inc.
Product code: Code BSR
Advisory panel: Anesthesiology
Date received: 1994-09-26
Decision date: 1994-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orange, CA, US

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Adverse events under product code BSR

product code BSR

Death: 2
Other: 1
Total: 3

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.