EPY · Speculum, Ent
General, Plastic Surgery · 21 CFR 878.1800 · Class 1
Overview
| Product Code | EPY |
|---|---|
| Device Name | Speculum, Ent |
| Regulation | 21 CFR 878.1800 |
| Device Class | Class 1 |
| Review Panel | General, Plastic Surgery |
Identification
A speculum is a device intended to be inserted into a body cavity to aid observation. It is either nonilluminated or illuminated and may have various accessories.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
Recent Cleared Devices (12 of 12)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K950086 | PEDIA PALS, INCORPORATED | Pedia Pals, Inc. | Feb 7, 1995 | SESE |
| K925754 | ECONOM | Rudolf Riester GmbH & Co. KG | Oct 8, 1993 | SESE |
| K853588 | FIBRELIGHT NASAL SPECULA | Downs Surgical , Ltd. | Dec 18, 1985 | SESE |
| K834189 | JAKOBI SURG. INSTRUMENTS #7 44/47 | Imm Enterprises , Ltd. | Mar 6, 1984 | SESE |
| K822373 | EAR SURGERY SPECULUM | Treace Medical, Inc. | Sep 9, 1982 | SESE |
| K822370 | UNIVERSAL SPECULUM HOLDER | Treace Medical, Inc. | Sep 9, 1982 | SESE |
| K822164 | EAR SPECULI | Kelleher Corp. | Aug 11, 1982 | SESE |
| K791123 | EAR AND NOSE SPECULA | Xomed, Inc. | Jul 10, 1979 | SESE |
| K780723 | OTOSCOPE SPECULA | Abco Dealers, Inc. | May 9, 1978 | SESE |
| K772385 | THIN-BLADED NASAL SPECULUM | Edward Weck, Inc. | Jan 17, 1978 | SESE |
| K772380 | FARRIOR OVAL SPECULUM | Edward Weck, Inc. | Jan 17, 1978 | SESE |
| K772370 | BARRAQUER OVAL SPECULUM-VARIOUS SIZES | Edward Weck, Inc. | Jan 17, 1978 | SESE |
Top Applicants
- Edward Weck, Inc. — 3 clearances
- Treace Medical, Inc. — 2 clearances
- Abco Dealers, Inc. — 1 clearance
- Downs Surgical , Ltd. — 1 clearance
- Imm Enterprises , Ltd. — 1 clearance
