← Product Code [FEW](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FEW) · K920423

# OLYMPIC SMART SCALE CARE CENTER (K920423)

_Olympic Medical Corp. · FEW · Jun 11, 1992 · Gastroenterology, Urology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FEW/K920423

## Device Facts

- **Applicant:** Olympic Medical Corp.
- **Product Code:** [FEW](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FEW.md)
- **Decision Date:** Jun 11, 1992
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 876.5090
- **Device Class:** Class 2
- **Review Panel:** Gastroenterology, Urology

## Regulatory Identification

A suprapubic urological catheter and accessories is a flexible tubular device that is inserted through the abdominal wall into the urinary bladder with the aid of a trocar and cannula. The device is used to pass fluids to and from the urinary tract. This generic type of device includes the suprapubic catheter and tube, Malecot catheter, catheter punch instrument, suprapubic drainage tube, and the suprapubic cannula and trocar.

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**Source:** [https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FEW/K920423](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FEW/K920423)

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