EPY — Speculum, Ent Class I
FDA product code EPY covers "Speculum, Ent", a Class I medical device regulated under 21 CFR 878.1800. Submissions are reviewed by the General, Plastic Surgery panel. At least 12 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- EPY
- Device Class
- Class I
- Regulation Number
- 878.1800
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K950086 | pedia pals | PEDIA PALS, INCORPORATED | February 7, 1995 |
| K925754 | rudolf riester gmbh and co. kg | ECONOM | October 8, 1993 |
| K853588 | downs surgical | FIBRELIGHT NASAL SPECULA | December 18, 1985 |
| K834189 | imm enterprises | JAKOBI SURG. INSTRUMENTS #7 44/47 | March 6, 1984 |
| K822370 | treace medical | UNIVERSAL SPECULUM HOLDER | September 9, 1982 |
| K822373 | treace medical | EAR SURGERY SPECULUM | September 9, 1982 |
| K822164 | kelleher | EAR SPECULI | August 11, 1982 |
| K791123 | xomed | EAR AND NOSE SPECULA | July 10, 1979 |
| K780723 | abco dealers | OTOSCOPE SPECULA | May 9, 1978 |
| K772370 | edward weck | BARRAQUER OVAL SPECULUM-VARIOUS SIZES | January 17, 1978 |
| K772385 | edward weck | THIN-BLADED NASAL SPECULUM | January 17, 1978 |
| K772380 | edward weck | FARRIOR OVAL SPECULUM | January 17, 1978 |