← Product Code [HFC](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HFC) · K954903

# PEDI VAGINAL ASPIRATOR (K954903)

_Cook Urological, Inc. · HFC · Apr 29, 1996 · Obstetrics/Gynecology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HFC/K954903

## Device Facts

- **Applicant:** Cook Urological, Inc.
- **Product Code:** [HFC](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HFC.md)
- **Decision Date:** Apr 29, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 884.1050
- **Device Class:** Class 2
- **Review Panel:** Obstetrics/Gynecology
- **Attributes:** Pediatric

## Indications for Use

The Pedi Vaginal Aspirator is used to aspirate vaginal secretions to evaluate female pediatric patients with vaginitis and/or possible sexual abuse.

## Device Story

Device: Pedi Vaginal Aspirator; used for aspiration of vaginal secretions. Input: vaginal secretions. Output: collected sample for clinical evaluation. Usage: clinical setting; operated by healthcare professionals. Benefit: facilitates diagnostic evaluation of pediatric patients presenting with vaginitis or suspected sexual abuse.

## Clinical Evidence

Bench testing only; no clinical data provided.

## Technological Characteristics

Materials: polyurethane and polyethylene. Form factor: catheter. Sterilization: standard procedures consistent with existing marketed devices.

## Regulatory Identification

An endocervical aspirator is a device designed to remove tissue from the endocervix (mucous membrane lining the canal of the cervix of the uterus) by suction with a syringe, bulb and pipette, or catheter. This device is used to evaluate endocervical tissue to detect malignant and premalignant lesions.

## Predicate Devices

- Bard® Rubber Utility Catheter, Radiopaque (Bard)

## Submission Summary (Full Text)

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K95 4903

APR 29 1996

510(k) Premarket Notification
Pedi Vaginal Aspirator
Cook OB/GYN

## I. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

### Submitted By:

Tammy Bacon
Cook OB/GYN
1100 West Morgan Street
Spencer, Indiana 47460
(812) 829-6500
October 24, 1995

### Device

Trade Name: Pedi Vaginal Aspirator
Proposed Classification Name: Catheter, Pediatric, General & Plastic Surgery

### Predicate Devices:

The Pedi Vaginal Aspirator is substantially equivalent to predicate devices in terms of indications for use.
Predicate devices include the Bard® Rubber Utility Catheter, Radiopaque manufactured by Bard.

### Device Description:

The Pedi Vaginal Aspirator is used to aspirate vaginal secretions to evaluate female pediatric patients with vaginitis and/or possible sexual abuse. This device will be made from polyurethane and polyethylene.

### Substantial Equivalence:

The device will be manufactured according to specified process controls and a Quality Assurance Program. The device will undergo packaging and sterilization procedures similar to devices currently marketed and distributed by Cook OB/GYN. Being similar with respect to indications for use and physical construction to predicate devices, this device meets the requirements for section 510(k) substantial equivalence.

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**Source:** [https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HFC/K954903](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HFC/K954903)

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