Inman Medical Packing Strip
by Inman Medical Corp. 510(k)
Active
510(k) K921291
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK921291 | Date21 Jan 1993 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 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
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.
Other devices from Inman Medical Corp.
Questions
AI-generated answers, 1 Oct 2026
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.