Retractor, Non-Self-Retaining
The Non-Self-Retaining Retractor is a handheld surgical instrument used by an assistant to manually hold tissue out of the operative field during gastrointestinal or urological surgery. It is classified as FDA Class 1, the lowest risk tier, subject only to general controls with no premarket notification required. The product code is FGN, regulated under 21 CFR 876.4730, within the Gastroenterology, Urology medical specialty.
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Basic Information
- Product Code
- FGN
- Device Class
- FDA class 1
- Regulation Number
- 876.4730
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 4
Device Characteristics
FEI Numbers
This FDA classification entry is associated with 70 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 70 registration numbers. Click on an entry to view related FDA registrations.