DIR 800
FDA 510(k) clearance K202391 · decided 2021-01-21
Clearance details
- K-number
- K202391
- Device name
- DIR 800
- Applicant
- Aesculap, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-08-21
- Decision date
- 2021-01-21
- Days to decision
- 153 days
- Clearance type
- Traditional
- Product code
- IZI
- Device class
- 2
- Regulation number
- 892.1600
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Center Valley, PA, US
- Third-party review
- No
- Expedited review
- No
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| EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004) (K234090) | Surgvision GmbH | 2024-03-20 |
| Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option) (K231075) | Carl Zeiss Meditec, Inc. | 2023-06-20 |
| SPY Portable Handheld Imaging (SPY-PHI) System (K230727) | Novadaq Technologies Ulc (A Part of Stryker) | 2023-06-05 |
| EXPLORER AIR® II (K222240) | Surgvision GmbH | 2023-02-28 |
| Explorer Air II (K214097) | Surgvision GmbH | 2022-02-25 |
| Asimov-MKS Imaging System (K192761) | Onlume, Inc. | 2020-01-17 |
| SURGICAL MICROSCOPE SYSTEM ORBEYE with IR (K190772) | Olympus Medical Systems Corp. | 2019-10-10 |
Recalls involving this device
No recalls on record reference this clearance.