Macan R-L33
Macan R-L33 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 00851683006625), 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 | Number00851683006625 | Date9 Nov 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK052622 | Date9 Dec 2005 | StatusActive |
Official records
- AccessGUDID record 00851683006625
- FDA 510(k) database K052622
Across registries
- FDA 510(k) K052622 decided 9 Dec 2005 Active
- FDA GUDID UDI-DI 00851683006625 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 00851683006625
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Macan
- Generic name
- Electrosurgical system
- Model / reference
- R-L33
- Primary DI / UDI-DI
- 00851683006625
- 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
Similar devices in this category
Other devices filed under Electrosurgical system.
- DIEGO ELITE BB2000SA by Gyrus Acmi, Inc.
- Vaporflex® JVHS32030 by JOIMAX, INC.
- DIEGO ELITE MDCONS100 by Gyrus Acmi, Inc.
- POTENZA Tip S-25 by Jeisys Medical Incorporated
- Voyant Maryland Fusion Device with Single-Step Activation EB213 by APPLIED MEDICAL RESOURCES CORP.
- Vaporflex® JVHS27527S by JOIMAX, INC.
- VOYANT® Maryland Fusion Device EB217 by APPLIED MEDICAL RESOURCES CORP.
- Wet-Field® Eraser 221266 by Beaver-Visitec International Inc
- SCARLET PRO by VIOL Co., Ltd.
- Wet-Field® Eraser® 221267 by Beaver-Visitec International Inc