Valleylab GR200A
by Covidien LP
Valleylab GR200A is a medical device (FDA Class II; FDA product code GEI, Electrosurgical, Cutting & Coagulation & Accessories) made by Covidien LP, cleared under FDA 510(k) K964636 on 11 Mar 1997 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 10884524002149), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10884524002149 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK964636 | Date11 Mar 1997 | StatusActive |
Official records
- AccessGUDID record 10884524002149
- FDA 510(k) database K964636
Across registries
- FDA 510(k) K964636 decided 11 Mar 1997 Active
- FDA GUDID UDI-DI 10884524002149 listed 24 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K964636
- Listed FDA GUDID 10884524002149
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Valleylab
- Generic name
- Argon-enhanced electrosurgical system gas delivery unit
- Model / reference
- GR200A
- Primary DI / UDI-DI
- 10884524002149
- 510(k) Number
- FDA product code
- GEI
- GMDN term
- Argon-enhanced electrosurgical system gas delivery unit
- Device class
- Class II
- Regulation number
- 878.4400
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code GEI (ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES).
- Laparoscopic 5MM ABC Probe, Modification by Birtcher Medical Systems, Inc.
- Gimmi Z.1335.32 by Gimmi GmbH
- Non-Stick Bipolar Forceps by Silverglide Surgical Technologies
- Guenter Bissinger Medizintechnik GmbH 80515201 by Günter Bissinger Medizintechnik GmbH
- HotDog Warming Mattress + Return Electrode by Augustine Temperature Management, LLC
- ERBE ESU MODEL VIO 100 C WITH ACCESSORIES by Erbe USA, Inc.
- Fractora by Invasix, Ltd.
- PEAK PLASMABLADE 3.OS TISSUE DISSECTION DEVICE by Peak Surgical, Inc.
- BIPOLAR COAGULATOR/IRRIAGATION SYSTEM by Valley Forge Scientific Corp.
- Force 4B Electrosurgical Generator by Valleylab, Inc.