← Product Code [EMX](/submissions/EN/subpart-e%E2%80%94surgical-devices/EMX) · K962133

# EXPANDACELL INJECTO-PAK (K962133)

_Shippert Medical Technologies Corp. · EMX · Aug 1, 1996 · Ear, Nose, Throat · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EMX/K962133

## Device Facts

- **Applicant:** Shippert Medical Technologies Corp.
- **Product Code:** [EMX](/submissions/EN/subpart-e%E2%80%94surgical-devices/EMX.md)
- **Decision Date:** Aug 1, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 874.4100
- **Device Class:** Class 1
- **Review Panel:** Ear, Nose, Throat
- **Attributes:** Therapeutic

## Indications for 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.

## Regulatory 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](/device/K935724.md)/S1)
- Expandacell Injecto-Pak ([K954845](/device/K954845.md))
- Expandacell Injecto-Pak ([K960228](/device/K960228.md))

## Submission Summary (Full Text)

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K962133 AUG - 1 1996

# SECTION 14 SMDA SUMMARY for Safety and Effectiveness

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the written requirements of SMDA 1990 and 21 CFR 807.92

## SAFETY AND EFFECTIVENESS OF EXPANDACELL INJECTO-PAK FOAM PACK FOR ADMINISTRATION OF LIQUID MEDICATION AND HYDRATING FOR THE SINUS

No specific medication is mentioned. The physician will choose medication indicated.

This proposed change to an already approved and marketed device does in no way alter the safety and effectiveness of this medical device. The Expandacell Sinus Pack K935724/S1, Expandacell Injecto-Pak, K954845, and the Expandacell Injecto-Pak K960228 have a proven track record that establishes this product line as safe to the post-operative nasal or post-operative sinus surgery patient. The modification of adapting this product for use in the sinus does not change the safety or effectiveness of this device.

The proposed product is identical in intended use, materials, anatomical sites, target population, physical safety, biocompatibility and performance to the predicate devices stated.

The Toxic Shock issue has been addressed in previous 510(k) applications and this product line addresses this issue on its instructions. Appropriate warning and directions are given for symptoms and appropriate care.

Signature
Sarah Maxwell Lake

Date
May 22, 1996

filename: 510KINJS.doc

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**Source:** [https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EMX/K962133](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EMX/K962133)

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