Product Code: PLI
FDA class 2
21 CFR 876.5980
Gastrointestional Tube Holder
Gastroenterology, Urology
The Gastrointestinal Tube Holder (product code PLI) is a Class 2 gastroenterology and urology device intended to support, secure, and hold gastrointestinal tubes in place, regulated under 876.5980. It requires 510(k) clearance for marketing. The device is not an implant and is not life-sustaining.
510(k)s
1
FEI Numbers
6
Registration Numbers
6
Unique Applicants
1
Years Active
—
Basic Information
- Product Code
- PLI
- Device Class
- FDA class 2
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 4
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
Definition
Intended to support, secure, and hold gastrointestinal tubes
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K961693 | DALE GASTROSTOMY TUBE HOLDER | Jul 30, 1996 | Substantially Equivalent | Dale Medical Products, Inc. |
FEI Numbers
This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.