ESTECH COBRA SURGICAL SYSTEM WITH THERMASHIELD ACCESSORY— 510(k) K110913

Substantially Equivalent

Endoscopic Technologies, Inc. D/B/A Estech

FDA 510(k) clearance K110913 for ESTECH COBRA SURGICAL SYSTEM WITH THERMASHIELD ACCESSORY, Substantially Equivalent on 2011-09-23. Applicant: Endoscopic Technologies, Inc. D/B/A Estech.

Clearance details

Applicant: Endoscopic Technologies, Inc. D/B/A Estech
Product code: Code OCL
Advisory panel: General, Plastic Surgery
Date received: 2011-04-01
Decision date: 2011-09-23
Decision: Substantially Equivalent
Clearance type: Special
Location: San Ramon, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OCL

product code OCL

Death: 34
Injury: 256
Total: 290

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.