Product code FXG
- Device name
- Specula Accessories
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.1800
- Review panel
- SU
- 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 |
|---|---|---|---|
| K891589 | 3MM DISPOSABLE SPECULA | Semantodontics, Inc. | 1989-04-18 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00850071684308 | REALSTAR SURGICAL INSTRUMENTS | REAL STAR SURGICAL INSTRUMENTS | 2025-09-09 |
| 04030155000774 | Reusable ear funnels Ø 4.0 mm, 10 pcs. | Kirchner & Wilhelm GmbH + Co KG | 2024-07-24 |
| 00840183503987 | BR Surgical, LLC | BR Surgical, LLC | 2024-02-06 |
| 00190776317799 | Millennium | Avalign Technologies, Inc. | 2023-11-13 |
| 04030155000682 | Ear funnel, grey, large Ø 4.0 mm, 10x100 pcs. in polybag | Kirchner & Wilhelm GmbH + Co KG | 2023-08-30 |
| 04030155000668 | Ear funnel, small, grey, Ø 2.5 mm, 10 x 100 pcs. in carton | Kirchner & Wilhelm GmbH + Co KG | 2023-08-30 |
| 04030155000651 | Ear funnel, grey, small Ø 2.5 mm, 10 x 100 pcs. in polybag | Kirchner & Wilhelm GmbH + Co KG | 2023-08-30 |
| 04030155000699 | Ear funnel, large, grey, Ø 4.0 mm, 10 x 100 pcs. in carton | Kirchner & Wilhelm GmbH + Co KG | 2023-08-30 |
| 04030155000637 | Ear funnel, black, large Ø 4.0 mm, in units of 100 pcs. | Kirchner & Wilhelm GmbH + Co KG | 2023-08-30 |
| 04030155000613 | Ear funnel, black, small Ø 2.5 mm, in units of 100 pcs. | Kirchner & Wilhelm GmbH + Co KG | 2023-08-30 |
| 00190776042479 | Avalign | Avalign Technologies, Inc. | 2023-06-23 |
| 00840183510725 | BR Surgical, LLC | BR Surgical, LLC | 2023-05-15 |
| 00840183506872 | BR Surgical, LLC | BR Surgical, LLC | 2023-05-15 |
| 54026704806305 | PILLING | TELEFLEX INCORPORATED | 2022-12-08 |
| 14026704806307 | PILLING | TELEFLEX INCORPORATED | 2022-12-08 |
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