EAR SPECULI
FDA 510(k) clearance K822164 · decided 1982-08-11
Clearance details
- K-number
- K822164
- Device name
- EAR SPECULI
- Applicant
- Kelleher Corp.
- Decision
- Substantially Equivalent
- Date received
- 1982-07-23
- Decision date
- 1982-08-11
- Days to decision
- 19 days
- Clearance type
- Traditional
- Product code
- EPY
- Device class
- 1
- Regulation number
- 878.1800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PEDIA PALS, INCORPORATED (K950086) | Pedia Pals, Inc. | 1995-02-07 |
| ECONOM (K925754) | Rudolf Riester GmbH & Co. KG | 1993-10-08 |
| FIBRELIGHT NASAL SPECULA (K853588) | Downs Surgical , Ltd. | 1985-12-18 |
| JAKOBI SURG. INSTRUMENTS #7 44/47 (K834189) | Imm Enterprises , Ltd. | 1984-03-06 |
| UNIVERSAL SPECULUM HOLDER (K822370) | Treace Medical, Inc. | 1982-09-09 |
| EAR SURGERY SPECULUM (K822373) | Treace Medical, Inc. | 1982-09-09 |
| EAR AND NOSE SPECULA (K791123) | Xomed, Inc. | 1979-07-10 |
| OTOSCOPE SPECULA (K780723) | Abco Dealers, Inc. | 1978-05-09 |
| THIN-BLADED NASAL SPECULUM (K772385) | Edward Weck, Inc. | 1978-01-17 |
| BARRAQUER OVAL SPECULUM-VARIOUS SIZES (K772370) | Edward Weck, Inc. | 1978-01-17 |
| FARRIOR OVAL SPECULUM (K772380) | Edward Weck, Inc. | 1978-01-17 |
Recalls involving this device
No recalls on record reference this clearance.