Erbe APCapplicators
510(k) K183445
Active
Valid until
No date given
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK183445 | Date4 Apr 2019 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA product code
- GEI
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4400
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Erbe APCapplicators are electrosurgical applicators designed for tissue coagulation and cutting in surgical procedures. These devices utilize high-frequency radio waves to achieve precise control over tissue effects, reducing bleeding and promoting hemostasis during general and plastic surgery interventions.
Supplied as single-use disposable applicators, these devices are intended for use in sterile surgical settings. They are classified under the EU MDR and granted FDA 510(k) clearance as substantially equivalent to predicate devices, adhering to strict regulatory standards. Available in various sizes and configurations, they are manufactured by Erbe Elektromedizin GmbH in Tuebingen, Germany, and must be stored according to manufacturer instructions to maintain sterility and performance.
Other devices from Erbe Elektromedizin GmbH
Questions
AI-generated answers, 18 Sep 2026
What types of surgical procedures are the Erbe APCapplicators primarily used for, and how do they help during these procedures?
The Erbe APCapplicators are designed for general and plastic surgery procedures, where they provide precise tissue coagulation and cutting using high-frequency radio waves. They help reduce bleeding and promote hemostasis, ensuring better control during surgical interventions by minimizing tissue damage while maintaining surgical precision.
Are the Erbe APCapplicators reusable or single-use, and what does this mean for their handling and storage?
The Erbe APCapplicators are supplied as single-use disposable devices, meaning each applicator is intended for one surgical procedure only. This design ensures sterility and reduces the risk of cross-contamination, requiring strict adherence to manufacturer storage instructions to maintain their performance and safety for intended use.
What sizes or configurations are available for the Erbe APCapplicators, and how might this affect their application in surgery?
The Erbe APCapplicators come in various sizes and configurations, allowing clinicians to select the appropriate tool for specific surgical needs. This versatility supports precision in both general and plastic surgery, enabling tailored tissue effects depending on the procedure and anatomical requirements.
How should the Erbe APCapplicators be stored to ensure they remain sterile and functional until use?
To maintain sterility and performance, the Erbe APCapplicators must be stored according to the manufacturer’s instructions, which likely include keeping them in their original packaging until use. Proper storage prevents contamination and ensures the applicators remain ready for sterile surgical environments as intended.
What regulatory pathways have the Erbe APCapplicators followed, and what does this mean for their use in clinical settings?
The Erbe APCapplicators have received FDA 510(k) clearance as substantially equivalent to predicate devices, and they comply with the EU Medical Device Regulation (MDR). This means they meet strict regulatory standards for safety and effectiveness, allowing clinicians to use them with confidence in approved surgical applications.