Qevo 7212
Qevo 7212 is a Class II device made by Carl Zeiss Meditec AG, cleared under FDA 510(k) K232159 on 21 Sep 2023 (1 earlier submission) and listed in FDA GUDID since 24 Aug 2017 (UDI-DI 04049539072122), 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 | FDA 510(k)SESE | NumberK232159 | Date21 Sep 2023 | StatusActive |
| United States | GUDID listing | Number04049539072122 | Date24 Aug 2017 | StatusListed |
Official records
- AccessGUDID record 04049539072122
- FDA 510(k) database K232159
- FDA 510(k) database K170667
Across registries
- FDA 510(k) K232159 decided 21 Sep 2023 Active
- FDA GUDID UDI-DI 04049539072122 listed 24 Aug 2017 Listed
Timeline
- Cleared FDA 510(k) K170667
- Listed FDA GUDID 04049539072122
- Cleared FDA 510(k) K232159
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Qevo
- Generic name
- Rigid optical intracranial/spinal endoscope, reusable
- Model / reference
- 7212
- Primary DI / UDI-DI
- 04049539072122
- FDA product code
- GWG
- GMDN term
- Rigid optical intracranial/spinal endoscope, reusable
- Device class
- Class II
- Regulation number
- 882.1480
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
- MRI safety
- MR Unsafe
Similar devices
Other devices filed under FDA product code GWG (Endoscope, Neurological).
- Neurological Endoscope by RICHARD WOLF MEDICAL INSTRUMENTS CORP.
- CLARUS SPINEPEN MODEL 2126 by Clarus Medical Systems, Inc.
- cCeLL - In vivo by VPIX Medical, Inc.
- Medtronic PS Medical Introducer Sheath 12F, 14F, 15F, Models 3805-012, 3805-014, 3805-015 by Medtronic PS Medical
- Disposable Bipolar Electrode by Neuro Navigational Corp.
- MINOP Disposable Introducer 26F by AESCULAP, INC.
- Endius Spine Endoscope by Endius, Inc.
- ASSISTO ARM SYSTEMS by Geomed Medizin-Technik GmbH & Co. KG
- KSEA NEURO-FIBERSCOPE by Karl Storz Endoscopy-America, Inc.
- PAEDISCOPE, MODEL # P010A AND PF011A by AESCULAP, INC.