ESTECH COBRA ADHERE XL 2 SURGICAL SYSTEM— 510(k) K113475
Substantially EquivalentEndoscopic Technologies, Inc. D/B/A Estech
FDA 510(k) clearance K113475 for ESTECH COBRA ADHERE XL 2 SURGICAL SYSTEM, Substantially Equivalent on 2012-03-20. Applicant: Endoscopic Technologies, Inc. D/B/A Estech. Device class: 2.
Clearance details
- Applicant
- Endoscopic Technologies, Inc. D/B/A Estech
- Product code
- Code OCL
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Ramon, CA, US
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- K210477 — AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE
More clearances from Endoscopic Technologies, Inc. D/B/A Estech
view allAdverse events under product code OCL
product code OCL- Death
- 34
- Injury
- 256
- Total
- 290
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 K113475
K-number listed on FDA's recall record- Z-0829-2019 — COBRA FUSION 50, Ablation System, Catalog # (REF) 700-002
- Z-0830-2019 — COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001
- Z-0831-2019 — COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001S
- Z-0832-2019 — COBRA FUSION 150 Ablation System (International Only), Catalog # (REF) 700-001MI
- Z-0653-2017 — COBRA Fusion 50 Ablation System, COBRA Fusion 150 Ablation System, and COBRA Fusion Magnetic Retriever System. Model Numbers: 700-001, 700-001S, 700-001MI, 700-002, and 700-003. Intended to ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy when connected directly to the Estech Electrosurgical unit (ESU).
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K113475.
Data sourced from openFDA. This site is unofficial and independent of the FDA.