Applicator, Ent Drug
FDA product code LRD · Class I (low risk) · 21 CFR 874.5220 · Ear, Nose, Throat
6510(k) clearances
0PMA approvals
1recalls
GMP exemptexempt from GMP rules
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K984345 | AromapatchLRD · Traditional | Envis, Inc. | 03/19/1999SE |
| K932522 | Amsco Sterile Recoveries Surgical PacksLRD · Traditional | Amsco Sterile Recoveries, Inc. | 09/09/1994SE |
| K942789 | MistassistLRD · Traditional | The Merlin Corp. | 08/12/1994SE |
| K940133 | The Expandacell Ear PackLRD · Traditional | Denver Splint Co. | 05/23/1994SE |
| K925022 | Surgical Tray (Sterile)LRD · Traditional | Customed, Inc. | 04/26/1993SE |
| K920842 | Aerosol Delivery SystemsLRD · Traditional | Hospitak, Inc. | 05/15/1992SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0435-2016 Class II | AbsorbENT, Sterile Compressed Absorbent Sponge, Nasal Pack, 8.9cm(L) x 3.0cm (W) x 1.5cm…Summit Medical is recalling Doyle P/F Nasal Pack w/Airway, string 8 cm x 3 cm x 1.5 cm, Catalog #… | Summit Medical, Inc. | 09/03/2015Terminated |