OTOVIEW ENDOSCOPY SYSTEM
FDA 510(k) clearance K934432 · decided 1994-04-25
Clearance details
- K-number
- K934432
- Device name
- OTOVIEW ENDOSCOPY SYSTEM
- Applicant
- Smith & Nephew Richards, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-09-13
- Decision date
- 1994-04-25
- Days to decision
- 224 days
- Clearance type
- Traditional
- Product code
- EWA
- Device class
- 1
- Regulation number
- 874.1080
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Bartlett, TN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Smith & Nephew Richards
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 |
|---|---|---|
| AUDIOMETER CALIBRATOR MODEL RA 310 (K780474) | Tracor Instruments, Inc. | 1978-03-30 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| OSTEOPAL (P810020/S005) | Smith & Nephew Richards, Inc. | 1998-10-15 |
| PALACOS E-FLOW (OSTEOPAL) BONE CEMENT (P810020/S004) | Smith & Nephew Richards, Inc. | 1998-07-30 |
| PALACOS R BONE CEMENT (P810020/S003) | Smith & Nephew Richards, Inc. | 1992-02-14 |
| PALACOS R BONE CEMENT (P810020/S002) | Smith & Nephew Richards, Inc. | 1989-01-30 |
| PALACOS R BONE CEMENT (P810020/S001) | Smith & Nephew Richards, Inc. | 1984-08-14 |
| PALACOS R BONE CEMENT (P810020) | Smith & Nephew Richards, Inc. | 1984-02-02 |