Bag, Intestine
Intestine Bag is a surgical accessory used to temporarily contain and protect exposed intestinal loops during abdominal surgical procedures, preventing drying and contamination of the bowel while the surgical field is maintained and the operative procedure proceeds. It is classified as FDA Class 1, the lowest risk category, subject to general controls only, meaning it does not require premarket notification or approval. The product code is KGY, regulated under 21 CFR 878.4100, within the General, Plastic Surgery medical specialty.
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Basic Information
- Product Code
- KGY
- Device Class
- FDA class 1
- Regulation Number
- 878.4100
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K933085 | GOODMAN BANDAGE | Dec 23, 1993 | Substantially Equivalent | Megadyne Medical Products, Inc. |
| K913678 | TROCAR CATHETER | Dec 16, 1991 | Substantially Equivalent | Medovations, Inc. |
| K910914 | SURGICAL TISSUE POUCH | Mar 28, 1991 | Substantially Equivalent | Cook Urological, Inc. |
| K832318 | ISOLATION BAG 3M | Oct 31, 1983 | Substantially Equivalent | 3M Company |
| K801824 | BAND-AID BRAND FLEXIBLE FABRIC BANDAGE | Aug 20, 1980 | Substantially Equivalent | Johnson & Johnson Professionals, Inc. |
| K801823 | BAND-AID BRAND TRICOT MESH BANDAGES | Aug 20, 1980 | Substantially Equivalent | Johnson & Johnson Professionals, Inc. |
FEI Numbers
This FDA classification entry is associated with 37 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 37 registration numbers. Click on an entry to view related FDA registrations.