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FDA 510(k)

Aesculap Caiman 12 Seal and Cut Technology System

K-Number: K203461 · 2020-12-18

ApplicantAesculap, Inc.
Decision Date2020-12-18
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Aesculap Caiman 12 Seal and Cut Technology System is a medical device manufactured by Aesculap, Inc.. It received FDA 510(k) clearance on 2020-12-18 under approval number K203461. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aesculap Caiman 12 Seal and Cut Technology System?

Aesculap Caiman 12 Seal and Cut Technology System is a medical device that received FDA 510(k) clearance on 2020-12-18. It is manufactured by Aesculap, Inc.. The 510(k) number is K203461.

When was Aesculap Caiman 12 Seal and Cut Technology System approved by the FDA?

Aesculap Caiman 12 Seal and Cut Technology System received FDA 510(k) clearance on 2020-12-18, under approval number K203461.

What company makes Aesculap Caiman 12 Seal and Cut Technology System?

Aesculap Caiman 12 Seal and Cut Technology System is manufactured by Aesculap, Inc..

What is the FDA product code for Aesculap Caiman 12 Seal and Cut Technology System?

The FDA product code for Aesculap Caiman 12 Seal and Cut Technology System is GEI.

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Related PubMed Literature

PMID: 39150225 Lessons on the use of real-world data in medical device research: findings from the National Evaluation System for Health Technology Test-Cases. Journal of comparative effectiveness research (2024) PMID: 37288633 [Roadmap of Medical Device for Implanted Brain-computer Interface]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2023) PMID: 37209414 Adverse events associated with Aveir Journal of cardiovascular electrophysiology (2023) PMID: 36632328 Integrating real-world data to assess cardiac ablation device outcomes in a multicenter study using the OMOP common data model for regulatory decisions: implementation and evaluation. JAMIA open (2023)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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