Product code JZF
- Device name
- Tube, Ear Suction
- 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 |
|---|---|---|---|
| K973587 | EXMOOR TYMPANOCENTESIS KIT (TK/1) | Exmoor Plastics , Ltd. | 1998-01-23 |
| K862903 | MIDDLE EAR VIEWER AND FLUID COLLECTOR | Steven K. Juhn | 1986-11-24 |
| K853589 | SHAH SELF-CLEARING MASTOID SUCTION TUBE | Downs Surgical , Ltd. | 1985-12-23 |
| K841357 | MICRO FLUID APPLICATOR | Treace Medical, Inc. | 1984-08-24 |
| K822010 | RIGID SUCTION TIPS & RELATED ITEMS | Kelleher Corp. | 1982-08-12 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| G043111510 | BEAR | Bear-Ent, LLC | 2026-07-08 |
| G043111520 | BEAR | Bear-Ent, LLC | 2026-07-08 |
| G043111540 | BEAR | Bear-Ent, LLC | 2026-07-08 |
| G043111550 | BEAR | Bear-Ent, LLC | 2026-07-08 |
| G043111560 | BEAR | Bear-Ent, LLC | 2026-07-08 |
| G043111570 | BEAR | Bear-Ent, LLC | 2026-07-08 |
| G043111580 | BEAR | Bear-Ent, LLC | 2026-07-08 |
| G043111590 | BEAR | Bear-Ent, LLC | 2026-07-08 |
| G043111600 | BEAR | Bear-Ent, LLC | 2026-07-08 |
| G043111500 | BEAR | Bear-Ent, LLC | 2026-07-08 |
| 05060212053503 | Barron Suction Handle (7Fg) | DTR MEDICAL LIMITED | 2026-06-10 |
| 05060212053589 | Oesophageal Suction Handle 550mm x 4mm OD (12Fg) | DTR MEDICAL LIMITED | 2026-06-10 |
| 05060212053572 | Bronchoscopy Suction Handle 450mm x 4mm OD (12Fg) | DTR MEDICAL LIMITED | 2026-06-10 |
| 05060212053565 | Micro Laryngeal Suction Handle, 360mm x 3mm OD (9Fg) | DTR MEDICAL LIMITED | 2026-06-10 |
| 05060212053558 | Micro Laryngeal Suction Handle 330mm x 3mm OD (9Fg) | DTR MEDICAL LIMITED | 2026-06-10 |
| 05060212053541 | Micro Laryngeal Suction Handle 330mm x 2mm OD (6Fg) | DTR MEDICAL LIMITED | 2026-06-10 |
| 05060212053534 | Micro Laryngeal Suction Handle 280mm x 2mm OD (6Fg) | DTR MEDICAL LIMITED | 2026-06-10 |
| 05060212053497 | Barron Suction Handle (6Fg) | DTR MEDICAL LIMITED | 2026-06-10 |
| 05060212053480 | Barron Suction Handle (5Fg) | DTR MEDICAL LIMITED | 2026-06-10 |
| 05060212053473 | Barron Suction Handle (4Fg) | DTR MEDICAL LIMITED | 2026-06-10 |
| 05060212053466 | Barron Suction Handle (3Fg) | DTR MEDICAL LIMITED | 2026-06-10 |
| 00840183530990 | BR Surgical, LLC | BR Surgical, LLC | 2025-09-05 |
| 05060411981386 | Brackmann type, 1.6mm x 115mm, 40 degree bend, suction control hole, open end | DTR MEDICAL LIMITED | 2024-10-14 |
| 05060411981560 | Zoellner type, 2mm x 85mm, 10 degree shallow distal bend, without suction contro | DTR MEDICAL LIMITED | 2024-10-14 |
| 05060411981577 | Zoellner type, 2mm x 85mm, distal bend acute 30 degree angle, without suction co | DTR MEDICAL LIMITED | 2024-10-14 |
| 05060411981799 | Zoellner type, 2mm x 85mm, distal bend acute 30 degree angle, without suction co | DTR MEDICAL LIMITED | 2024-10-14 |
| 05060411981805 | Zoellner type, 2mm x 85mm, 10 degree shallow distal bend, with suction control h | DTR MEDICAL LIMITED | 2024-10-14 |
| 05060411981812 | Zoellner type, 2mm x 85mm, distal bend acute 30 degree angle, with suction contr | DTR MEDICAL LIMITED | 2024-10-14 |
| 05060411981829 | Zoellner type, 2mm x 85mm, distal bend acute 30 degree angle, with suction contr | DTR MEDICAL LIMITED | 2024-10-14 |
| 05060411981836 | Belucci type, 2mm x 85mm, proximal bend with suction control hole | DTR MEDICAL LIMITED | 2024-10-14 |