Product code EPY
- Device name
- Speculum, Ent
- 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 |
|---|---|---|---|
| K950086 | PEDIA PALS, INCORPORATED | Pedia Pals, Inc. | 1995-02-07 |
| K925754 | ECONOM | Rudolf Riester GmbH & Co. KG | 1993-10-08 |
| K853588 | FIBRELIGHT NASAL SPECULA | Downs Surgical , Ltd. | 1985-12-18 |
| K834189 | JAKOBI SURG. INSTRUMENTS #7 44/47 | Imm Enterprises , Ltd. | 1984-03-06 |
| K822370 | UNIVERSAL SPECULUM HOLDER | Treace Medical, Inc. | 1982-09-09 |
| K822373 | EAR SURGERY SPECULUM | Treace Medical, Inc. | 1982-09-09 |
| K822164 | EAR SPECULI | Kelleher Corp. | 1982-08-11 |
| K791123 | EAR AND NOSE SPECULA | Xomed, Inc. | 1979-07-10 |
| K780723 | OTOSCOPE SPECULA | Abco Dealers, Inc. | 1978-05-09 |
| K772370 | BARRAQUER OVAL SPECULUM-VARIOUS SIZES | Edward Weck, Inc. | 1978-01-17 |
| K772380 | FARRIOR OVAL SPECULUM | Edward Weck, Inc. | 1978-01-17 |
| K772385 | THIN-BLADED NASAL SPECULUM | Edward Weck, Inc. | 1978-01-17 |
Related GUDID Devices#
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|---|---|---|---|
| 04054462156481 | evonos | evonos GmbH & Co. KG | 2026-08-26 |
| 04054462902484 | evonos | evonos GmbH & Co. KG | 2026-08-21 |
| 04054462904969 | evonos | evonos GmbH & Co. KG | 2026-08-21 |
| 04054462904952 | evonos | evonos GmbH & Co. KG | 2026-08-21 |
| 04054462904945 | evonos | evonos GmbH & Co. KG | 2026-08-21 |
| 04054462904938 | evonos | evonos GmbH & Co. KG | 2026-08-21 |
| 04054462904914 | evonos | evonos GmbH & Co. KG | 2026-08-21 |
| 04054462904907 | evonos | evonos GmbH & Co. KG | 2026-08-21 |
| 04054462904891 | evonos | evonos GmbH & Co. KG | 2026-08-21 |
| 04054462904884 | evonos | evonos GmbH & Co. KG | 2026-08-21 |
| 04054462904877 | evonos | evonos GmbH & Co. KG | 2026-08-21 |
| 04054462902538 | evonos | evonos GmbH & Co. KG | 2026-08-21 |
| 04054462902521 | evonos | evonos GmbH & Co. KG | 2026-08-21 |
| 04054462902514 | evonos | evonos GmbH & Co. KG | 2026-08-21 |
| 04054462902507 | evonos | evonos GmbH & Co. KG | 2026-08-21 |
| 04054462902491 | evonos | evonos GmbH & Co. KG | 2026-08-21 |
| 04054462902477 | evonos | evonos GmbH & Co. KG | 2026-08-21 |
| 04054462902460 | evonos | evonos GmbH & Co. KG | 2026-08-21 |
| 04054462902453 | evonos | evonos GmbH & Co. KG | 2026-08-21 |
| 04054462902446 | evonos | evonos GmbH & Co. KG | 2026-08-21 |
| 04054462902439 | evonos | evonos GmbH & Co. KG | 2026-08-21 |
| 04054462902422 | evonos | evonos GmbH & Co. KG | 2026-08-21 |
| 04054462902415 | evonos | evonos GmbH & Co. KG | 2026-08-21 |
| 04054462902408 | evonos | evonos GmbH & Co. KG | 2026-08-21 |
| 04054462902385 | evonos | evonos GmbH & Co. KG | 2026-08-21 |
| 04054462902330 | evonos | evonos GmbH & Co. KG | 2026-08-21 |
| 04054462902316 | evonos | evonos GmbH & Co. KG | 2026-08-21 |
| 04054462902309 | evonos | evonos GmbH & Co. KG | 2026-08-21 |
| 04054462902293 | evonos | evonos GmbH & Co. KG | 2026-08-21 |
| 04054462902286 | evonos | evonos GmbH & Co. KG | 2026-08-21 |