KAG · Holder, Speculum, Ent
General, Plastic Surgery · 21 CFR 878.1800 · Class 1
Overview
| Product Code | KAG |
|---|---|
| Device Name | Holder, 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 (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K842931 | DRABKIN REAGENT | E K Ind., Inc. | Sep 21, 1984 | SESE |
| K822857 | CPI PRINTER | Cardiac Pacemakers, Inc. | Jan 8, 1983 | SESE |
Top Applicants
- Cardiac Pacemakers, Inc. — 1 clearance
- E K Ind., Inc. — 1 clearance
