Macan R-L35
Macan R-L35 is a Class II device made by Macan Manufacturing, cleared under FDA 510(k) K052622 on 9 Dec 2005 and listed in FDA GUDID since 9 Nov 2016 (UDI-DI 00851683006649), active as of 22 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00851683006649 | Date9 Nov 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK052622 | Date9 Dec 2005 | StatusActive |
Official records
- AccessGUDID record 00851683006649
- FDA 510(k) database K052622
Across registries
- FDA 510(k) K052622 decided 9 Dec 2005 Active
- FDA GUDID UDI-DI 00851683006649 listed 9 Nov 2016 Listed
Recalls
-
- Terminated Z-0810-06
The product label fails to warn users to use the device on patients with shielded pacemakers only.
Timeline
- Cleared FDA 510(k) K052622
- Recall initiated FDA recalls Z-0810-06
- Listed FDA GUDID 00851683006649
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Macan
- Generic name
- Electrosurgical system
- Model / reference
- R-L35
- Primary DI / UDI-DI
- 00851683006649
- 510(k) Number
- FDA product code
- EKZ
- GMDN term
- Electrosurgical system
- Device class
- Class II
- Regulation number
- 872.4920
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
- Size
- Outer Diameter — 0.0625 Inch
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