OPTICAL MEDIASTINOSCOPE WITH PLUG-IN CONNECTION/OCULAR EYEPIECE
FDA 510(k) clearance K971166 · decided 1997-08-27
Clearance details
- K-number
- K971166
- Device name
- OPTICAL MEDIASTINOSCOPE WITH PLUG-IN CONNECTION/OCULAR EYEPIECE
- Applicant
- Richard Wolf Medical Instruments Corp.
- Decision
- Substantially Equivalent
- Date received
- 1997-03-31
- Decision date
- 1997-08-27
- Days to decision
- 149 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
- Vernon Hills, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Richard Wolf Medical Instruments Corp.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |
| HD Mediastinoscope (K202272) | Karl Storz Endoscopy America, Inc. | 2021-05-11 |
| 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 |
| 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 |
|---|---|---|
| HULKA CLIP FOR TUBAL OCCLUSION (P870080/S002) | Richard Wolf Medical Instruments Corp. | 2016-10-14 |
| HULKA CLIP FOR TUBAL OCCLUSION (P870080/S001) | Richard Wolf Medical Instruments Corp. | 1998-03-12 |
| HULKA CLIP FOR TUBAL OCCLUSION (P870080) | Richard Wolf Medical Instruments Corp. | 1996-09-05 |
| RICHARD WOLF PIEZOLITH E.L.P. LITHOTRIPT MODEL2300 (P890013) | Richard Wolf Medical Instruments Corp. | 1991-09-09 |