Product code KTE
- Device name
- Trocar, Ent
- Medical specialty
- Ear, Nose, Throat
- Device class
- 1
- Regulation number
- 874.4420
- Review panel
- EN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K822168 | ANTRUM TROCARS | Kelleher Corp. | 1982-08-16 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 05055445930615 | Surtex | SURTEX INSTRUMENTS LTD. | 2026-05-12 |
| 05055445930622 | Surtex | SURTEX INSTRUMENTS LTD. | 2026-05-12 |
| 05055445930639 | Surtex | SURTEX INSTRUMENTS LTD. | 2026-05-12 |
| 05055445930646 | Surtex | SURTEX INSTRUMENTS LTD. | 2026-05-12 |
| 05055445930653 | Surtex | SURTEX INSTRUMENTS LTD. | 2026-05-12 |
| 05055445930660 | Surtex | SURTEX INSTRUMENTS LTD. | 2026-05-12 |
| 04046826472153 | Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 2025-12-17 |
| 04250381812860 | Antrum trocar, oblique beak | Spiggle & Theis Medizintechnik GmbH | 2025-10-05 |
| 04250381812846 | Antrum trocar, beaked | Spiggle & Theis Medizintechnik GmbH | 2025-09-10 |
| 04250381812853 | Antrum trocar, oblique beak | Spiggle & Theis Medizintechnik GmbH | 2025-09-10 |
| 04250381812877 | Antrum trocar, oblique beak | Spiggle & Theis Medizintechnik GmbH | 2025-09-10 |
| 00757770422029 | Bausch + Lomb | Bausch & Lomb Incorporated | 2024-11-21 |
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| 10885403111297 | V. Mueller | STERIS CORPORATION | 2018-09-14 |
| 10885403111303 | V. Mueller | STERIS CORPORATION | 2018-09-14 |
| 10885403111310 | V. Mueller | STERIS CORPORATION | 2018-09-14 |
| 08809282812828 | Surgical Instrument | Jeil Medical Corporation | 2018-09-07 |
| 10381780159773 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-14 |