KGY · Bag, Intestine
General, Plastic Surgery · 21 CFR 878.4100 · Class 1
Overview
| Product Code | KGY |
|---|---|
| Device Name | Bag, Intestine |
| Regulation | 21 CFR 878.4100 |
| Device Class | Class 1 |
| Review Panel | General, Plastic Surgery |
Identification
An organ bag is a device that is a flexible plastic bag intended to be used as a temporary receptacle for an organ during surgical procedures to prevent moisture loss.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
Recent Cleared Devices (6 of 6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K933085 | GOODMAN BANDAGE | Megadyne Medical Products, Inc. | Dec 23, 1993 | SESE |
| K913678 | TROCAR CATHETER | Medovations, Inc. | Dec 16, 1991 | SESE |
| K910914 | SURGICAL TISSUE POUCH | Cook Urological, Inc. | Mar 28, 1991 | SESE |
| K832318 | ISOLATION BAG 3M | 3M Company | Oct 31, 1983 | SESE |
| K801824 | BAND-AID BRAND FLEXIBLE FABRIC BANDAGE | Johnson & Johnson Professionals, Inc. | Aug 20, 1980 | SESE |
| K801823 | BAND-AID BRAND TRICOT MESH BANDAGES | Johnson & Johnson Professionals, Inc. | Aug 20, 1980 | SESE |
Top Applicants
- Johnson & Johnson Professionals, Inc. — 2 clearances
- 3M Company — 1 clearance
- Cook Urological, Inc. — 1 clearance
- Medovations, Inc. — 1 clearance
- Megadyne Medical Products, Inc. — 1 clearance
