LRD · Applicator, Ent Drug
Ear, Nose, Throat · 21 CFR 874.5220 · Class 1
Overview
| Product Code | LRD |
|---|---|
| Device Name | Applicator, Ent Drug |
| Regulation | 21 CFR 874.5220 |
| Device Class | Class 1 |
| Review Panel | Ear, Nose, Throat |
| GMP Exempt | Yes |
Identification
An ear, nose, and throat drug administration device is one of a group of ear, nose, and throat devices intended specifically to administer medicinal substances to treat ear, nose, and throat disorders. These instruments include the powder blower, dropper, ear wick, manual nebulizer pump, and nasal inhaler.
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 § 874.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (6 of 6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K984345 | AROMAPATCH | Envis, Inc. | Mar 19, 1999 | SESE |
| K932522 | AMSCO STERILE RECOVERIES SURGICAL PACKS | Amsco Sterile Recoveries, Inc. | Sep 9, 1994 | SESE |
| K942789 | MISTASSIST | The Merlin Corp. | Aug 12, 1994 | SESE |
| K940133 | THE EXPANDACELL EAR PACK | Denver Splint Co. | May 23, 1994 | SESE |
| K925022 | SURGICAL TRAY (STERILE) | Customed, Inc. | Apr 26, 1993 | SESE |
| K920842 | AEROSOL DELIVERY SYSTEMS | Hospitak, Inc. | May 15, 1992 | SESE |
Top Applicants
- Amsco Sterile Recoveries, Inc. — 1 clearance
- Customed, Inc. — 1 clearance
- Denver Splint Co. — 1 clearance
- Envis, Inc. — 1 clearance
- Hospitak, Inc. — 1 clearance
