Product code KCP
- Device name
- Syringe, Ent
- Medical specialty
- Ear, Nose, Throat
- Device class
- 1
- Regulation number
- 874.5220
- Review panel
- EN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K840311 | CAT. 7-EAR, NOSE & THROAT DEVICES | Imm Enterprises , Ltd. | 1984-05-09 |
| K822754 | EAR/ULCER SYRINGE | American Hospital Supply Corp. | 1982-10-04 |
| K810284 | AUTOMATIC TEFLON INJECTION SYRINGE | R. Wolf Medical Instruments Corp. | 1981-03-11 |
| K780599 | SYRINGE, EAR & ULCER | Abco Dealers, Inc. | 1978-04-19 |
Related GUDID Devices#
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|---|---|---|---|
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| 16971919460432 | Medi Grade | Ningbo Albert Novosino Co.,Ltd. | 2025-11-11 |
| 00661392027701 | LSL HEALTHCARE | LSL Industries, LLC | 2025-10-30 |
| 00661392012486 | LSL HEALTHCARE | LSL Industries, LLC | 2025-10-30 |
| 00661392010437 | LSL HEALTHCARE | LSL Industries, LLC | 2025-10-30 |
| 00661392001855 | LSL HEALTHCARE | LSL Industries, LLC | 2025-10-30 |
| 00194613112639 | MSI Precision Specialty Instruments | Med Saver, Inc. | 2025-08-01 |
| 00194613021535 | MSI Precision Specialty Instruments | Med Saver, Inc. | 2025-08-01 |
| 00757770410651 | Bausch + Lomb | Bausch & Lomb Incorporated | 2025-07-29 |
| 00661392010444 | LSL HEALTHCARE | LSL Industries, LLC | 2025-05-16 |
| 00661392010451 | LSL HEALTHCARE | LSL Industries, LLC | 2025-05-16 |
| 00661392010802 | LSL HEALTHCARE | LSL Industries, LLC | 2025-05-16 |
| 00661392013414 | LSL HEALTHCARE | LSL Industries, LLC | 2025-05-16 |
| 00661392045392 | LSL HEALTHCARE | LSL Industries, LLC | 2025-05-16 |
| 00714646000576 | OtoClear Tip Sample | Bionix, LLC | 2024-07-11 |
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| 00884392949471 | Safety 1st | DOREL JUVENILE GROUP, INC. | 2023-11-15 |
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