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#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| G043714000 | BEAR | Bear-Ent, LLC | 2026-05-07 |
| G04371401G0 | GEIZ | Bear-Ent, LLC | 2026-05-07 |
| G04371402G0 | GEIZ | Bear-Ent, LLC | 2026-05-07 |
| G04371403G0 | GEIZ | Bear-Ent, LLC | 2026-05-07 |
| 09348811116673 | INKA | The Trustee for KAISER FAMILY TRUST | 2026-04-24 |
| 09348811116925 | INKA | The Trustee for KAISER FAMILY TRUST | 2026-03-18 |
| 09348811148995 | INKA | The Trustee for KAISER FAMILY TRUST | 2025-11-21 |
| 09348811116345 | INKA | The Trustee for KAISER FAMILY TRUST | 2025-11-21 |
| 09348811116369 | INKA | The Trustee for KAISER FAMILY TRUST | 2025-11-21 |
| 09348811116383 | INKA | The Trustee for KAISER FAMILY TRUST | 2025-11-21 |
| 09348811116406 | INKA | The Trustee for KAISER FAMILY TRUST | 2025-11-21 |
| 09348811116413 | INKA | The Trustee for KAISER FAMILY TRUST | 2025-11-21 |
| 08906039319538 | OSSEOUS Ear Specula | EON MEDITECH PRIVATE LIMITED | 2024-07-04 |
| 08906039319521 | OSSEOUS Ear Specula | EON MEDITECH PRIVATE LIMITED | 2024-07-04 |
| 08906039319514 | OSSEOUS Ear Specula | EON MEDITECH PRIVATE LIMITED | 2024-07-04 |
| 08906039319545 | OSSEOUS Ear Specula | EON MEDITECH PRIVATE LIMITED | 2024-07-04 |
| G043608500 | BEAR | Bear-Ent, LLC | 2022-05-23 |
| 10381780189961 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-03 |
| 10381780189954 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-03 |
| 10381780189947 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-03 |
| 10381780189930 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-03 |
| 10381780189923 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-03 |
| 10381780189916 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-03 |
| 10381780189909 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-03 |
| 10381780189893 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-03 |
| 10381780189886 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-03 |
| 10381780189879 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-03 |
| 10381780166863 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-02-16 |
| 10381780166870 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-06-27 |
| 10381780136545 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-14 |