OTOVIEW TELESCOPIC OTOSCOPES
FDA 510(k) clearance K943721 · decided 1994-11-18
Clearance details
- K-number
- K943721
- Device name
- OTOVIEW TELESCOPIC OTOSCOPES
- Applicant
- Smith & Nephew, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-08-01
- Decision date
- 1994-11-18
- Days to decision
- 109 days
- Clearance type
- Traditional
- Product code
- ERA
- Device class
- 1
- Regulation number
- 874.4770
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Bartlett, TN, 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 |
|---|---|---|
| AIO HD OTOSCOPE (K123821) | Blue Focus | 2013-05-17 |
| LANTOS 3D EAR SCANNER (K121326) | Lantos Technologies | 2013-01-25 |
| OSRAM ITOS (K110326) | Osram Sylvania, Inc. | 2011-10-27 |
| OPTUS OTOSCOPES (K945264) | Optus, Inc. | 1996-02-02 |
| WELCH ALLYN BI-OTOSCOPE (K955043) | Welch Allyn, Inc. | 1995-11-14 |
| WELCH ALLY OTOSCOPE (K952578) | Welch Allyn, Inc. | 1995-07-10 |
| PERFECT, ENT SET, PRAKTIKANT, DE LUXE (K950913) | Rudolf Riester GmbH & Co. KG | 1995-05-12 |
| OTOSCOPE A-34 (K950788) | Neitz Instruments Company, Ltd. | 1995-05-03 |
| SPECULUM, ENT (S3) (K951050) | Pedia Pals, Inc. | 1995-04-17 |
| SPECULUM, ENT (S3) (K951049) | Pedia Pals, Inc. | 1995-04-17 |
| IMEDGE VIDEO OSTOSCOPE (ANALOG) (K951255) | Introspect, Inc. | 1995-04-13 |
| IMEDGE DIGITA OTOSCOPE OR DIGITAL VIDEO OTOSCOPE (K950983) | Introspect, Inc. | 1995-04-12 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Ascension MCP (P000057/S013) | Smith & Nephew, Inc. | 2025-12-31 |
| ASCENSION MCP (P000057/S014) | Smith & Nephew, Inc. | 2025-08-05 |
| R3 Delta Ceramic Acetabular System (P150030/S049) | Smith & Nephew, Inc. | 2025-04-17 |
| R3 DELTA CERAMIC HIP SYSTEM (P150030/S048) | Smith & Nephew, Inc. | 2025-03-03 |
| R3 Delta Ceramic Hip System (P150030/S045) | Smith & Nephew, Inc. | 2025-02-28 |
| R3 Delta Ceramic Acetabular System (P150030/S047) | Smith & Nephew, Inc. | 2025-02-21 |
| R3 Delta Ceramic Acetabular System (P150030/S046) | Smith & Nephew, Inc. | 2025-01-16 |
| BIRMINGHAM HIP RESURFACING (BHR) SYSTEM (P040033/S039) | Smith & Nephew, Inc. | 2025-01-10 |