Product Code: FHI FDA class 1 21 CFR 876.4730

Ring, Laparotomy

Gastroenterology, Urology

The Laparotomy Ring is a surgical accessory used to maintain exposure of the abdominal cavity during open laparotomy procedures, typically as part of a wound retraction and protection system. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is FHI, regulated under 21 CFR 876.4730, within the Gastroenterology, Urology medical specialty.

510(k)s
0
FEI Numbers
21
Registration Numbers
21
Unique Applicants
0
Years Active

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Basic Information

Product Code
FHI
Device Class
FDA class 1
Regulation Number
876.4730
Medical Specialty
Gastroenterology, Urology
Review Panel
GU
Submission Type
4

Device Characteristics

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

FEI Numbers

This FDA classification entry is associated with 21 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 21 registration numbers. Click on an entry to view related FDA registrations.