EXPANDACELL INJECTO-PAK
Device Facts
| Record ID | K962133 |
|---|---|
| Device Name | EXPANDACELL INJECTO-PAK |
| Applicant | Shippert Medical Technologies Corp. |
| Product Code | EMX · Ear, Nose, Throat |
| Decision Date | Aug 1, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 874.4100 |
| Device Class | Class 1 |
| Attributes | Therapeutic |
Intended Use
The Expandacell Injecto-Pak Foam Pack is intended for the administration of liquid medication and hydrating for the sinus.
Device Story
Expandacell Injecto-Pak foam pack; used for delivery of liquid medication or hydration to sinus cavities post-surgery. Device functions as a carrier/applicator for physician-selected medications. Used in clinical settings by physicians; provides localized treatment to nasal/sinus tissues. Benefits include controlled delivery of therapeutic agents and hydration to surgical sites. Safety profile addresses toxic shock concerns via labeling, warnings, and instructions for use.
Clinical Evidence
No clinical data; substantial equivalence based on identical design, materials, and performance characteristics to previously cleared predicate devices.
Technological Characteristics
Foam-based delivery system; biocompatible materials consistent with previously cleared Expandacell product line. No electronic components, software, or energy sources.
Indications for Use
Indicated for post-operative nasal or post-operative sinus surgery patients requiring administration of liquid medication or hydration to the sinus.
Regulatory Classification
Identification
An epistaxis balloon is a device consisting of an inflatable balloon intended to control internal nasal bleeding by exerting pressure against the sphenopalatine artery.
Predicate Devices
- Expandacell Sinus Pack (K935724/S1)
- Expandacell Injecto-Pak (K954845)
- Expandacell Injecto-Pak (K960228)
Related Devices
- K964113 — IVALON NASAL PACKING W/DRAWSTRING (8.0CM & 4.5CM), IVALON NASAL PACKING W/AIRWAY TUBE & DRAWSTRING, IVALON CONTOUR NASAL · M-Pact Worldwide Management Corp. · Nov 7, 1996
- K973085 — ULTRACELL PACKING WITH SLEEVE · Ultracell Medical Technologies, Inc. · Nov 18, 1997
- K972077 — EPI-STOP EPISTAXIS CATHETER · Boston Medical Products, Inc. · Jun 26, 1997
- K072891 — SINUS SPACER · Acclarent, Inc. · Mar 19, 2008
- K983276 — HYDROFERA BACTERISTATIC NASAL DRESSING · Hydrofera, LLC · Sep 14, 1999
