OtoSet- Ear Cleaning System
FDA 510(k) clearance K201877 · decided 2020-11-05
Clearance details
- K-number
- K201877
- Device name
- OtoSet- Ear Cleaning System
- Applicant
- Safkan, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-07-07
- Decision date
- 2020-11-05
- Days to decision
- 121 days
- Clearance type
- Traditional
- Product code
- KYZ
- Device class
- 1
- Regulation number
- 880.6960
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Tucson, AZ, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
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| ZEROWET SPLASHIELD (K974288) | Zerowet, Inc. | 1998-01-29 |
| RMI DUAL FLUID IRRIGATING SYRINGE (K964833) | Research Medical, Inc. | 1997-02-19 |
| MARPP PRESSURE MONITORING SYSTEM (K960725) | Paradigm Medical, Inc. | 1996-07-15 |
| CPR IRRIGATION TRAY (K960212) | Custom Pack Reliability | 1996-04-01 |
| REDI NURSE SYSTEM (RNS) PRE-FILLED 60CC IRRIGATION SYRINGE W/STERILE SODIUM CHLORIDE SOLUTION (K952406) | Contour Fabricators of Florida, Inc. | 1995-08-07 |
| REDI NURSE SYSTEM (RNS) PRE-FILLED 10CC, 30CC, 60CC SYRINGE W/STERILE WATER (K952407) | Contour Fabricators of Florida, Inc. | 1995-08-07 |
| INMAN IRRIGATION TAPERED PROBE (K933171) | Inman Medical Corp. | 1994-04-29 |
Recalls involving this device
No recalls on record reference this clearance.