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Inman Medical Packing Strip

by Inman Medical Corp. 510(k)

Active United States

510(k) K921291

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK921291 Date21 Jan 1993ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
FER
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Inman Medical Packing Strip is a medical device classified as an accessory for an anoscope, used for wound packing procedures. It is designed to be absorbent and suitable for medical applications in gastroenterology and urology.

This device is supplied as a sterile, single-use product and is available in various sizes. It received FDA 510(k) clearance on January 21, 1993, with product code FER and is regulated under 876.1500.

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Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Inman Medical Packing Strip used for?

    The Inman Medical Packing Strip is designed as an accessory for an anoscope, specifically for wound packing procedures in gastroenterology and urology medical applications. It is absorbent and intended for use in these specialized medical fields.

  • Is the Inman Medical Packing Strip reusable or single-use?

    The Inman Medical Packing Strip is supplied as a sterile, single-use product. This means it should be used only once for a single patient procedure and then properly disposed of according to medical waste protocols to ensure patient safety and prevent cross-contamination.

  • What sizes are available for the Inman Medical Packing Strip?

    The Inman Medical Packing Strip is available in various sizes to accommodate different clinical needs and anatomical considerations during wound packing procedures. The specific size options should be selected based on the clinical requirements of each individual case.

  • What is the regulatory status of the Inman Medical Packing Strip?

    The Inman Medical Packing Strip received FDA 510(k) clearance on January 21, 1993, with product code FER and is regulated under 876.1500. It is classified as a Class 2 medical device and is considered substantially equivalent to predicate devices in the gastroenterology and urology fields.