HD Mediastinoscope
FDA 510(k) clearance K202272 · decided 2021-05-11
Clearance details
- K-number
- K202272
- Device name
- HD Mediastinoscope
- Applicant
- Karl Storz Endoscopy America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-08-11
- Decision date
- 2021-05-11
- Days to decision
- 273 days
- Clearance type
- Traditional
- Product code
- EWY
- Device class
- 2
- Regulation number
- 874.4720
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- El Segundo, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| KARL STORZ Mediastinoscopes and Instruments (K260003) | Karl Storz SE & CO. KG | 2026-03-02 |
| HD Mediastinoscope (K213194) | Karl Storz Endoscopy America, Inc. | 2022-06-23 |
| Aegis Transit System (K170757) | Boston-Biomedical Associates | 2017-07-14 |
| Illuminated Mediastinal Access Port (K160171) | Aegis Surgical, Ltd. | 2016-02-26 |
| ILLUMINATED MEDIASTINOSCOPE (K141622) | Aegis Surgical, Ltd. | 2015-01-09 |
| OPTICAL MEDIASTINOSCOPE WITH PLUG-IN CONNECTION/OCULAR EYEPIECE (K971166) | Richard Wolf Medical Instruments Corp. | 1997-08-27 |
| KARL STORZ OPTICAL MEDIASTINOSCOPE (K954910) | KARL STORZ Endoscopy-America, Inc. | 1995-11-03 |
| FLEXIBLE TROCAR TUBES (K930215) | Olympus Corp. | 1993-03-16 |
| OLYMPUS FLEXIBLE TIP THORACOSCOPE (K913829) | Olympus Corp. | 1991-11-22 |
| OES THORACOSCOPE SYSTEM (K912362) | Olympus Corp. | 1991-10-24 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Photodynamic Diagnostic D-Light C System (P050027/S034) | KARL STORZ Endoscopy-America, Inc. | 2025-10-01 |
| KARL STORZ Photodynamic Diagnostic D-Light C (PDD) System (P050027/S033) | KARL STORZ Endoscopy-America, Inc. | 2025-05-02 |
| KARL STORZ Photodynamic Diagnostic D-Light C (PDD) System (P050027/S032) | KARL STORZ Endoscopy-America, Inc. | 2024-09-27 |
| KARL STORZ D-Light C PDD System (P050027/S031) | KARL STORZ Endoscopy-America, Inc. | 2023-05-05 |
| KARL STORZ D-Light C PDD System (P050027/S030) | KARL STORZ Endoscopy-America, Inc. | 2022-03-17 |
| KARL STORZ D-Light C PDD System (P050027/S028) | KARL STORZ Endoscopy-America, Inc. | 2022-02-04 |
| KARL STORZ D-Light C PDD System (P050027/S029) | KARL STORZ Endoscopy-America, Inc. | 2021-10-13 |
| D-Light C PDD System (P050027/S027) | KARL STORZ Endoscopy-America, Inc. | 2021-01-08 |