FDA product code KGY: Bag, Intestine
KGY is the FDA product code for bag, intestine. It is a Class I device, regulated under 21 CFR 878.4100 and reviewed by the General and Plastic Surgery panel. FDA has cleared 6 510(k) submissions under KGY, from 5 different applicants. The average 510(k) review took 79 days (median 66). FDA has posted 1 recall for KGY devices.
Classification
| Field | Value |
|---|---|
| Device name | Bag, Intestine |
| Device class | Class I |
| Regulation | 21 CFR 878.4100 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KGY clearance
Top KGY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Johnson & Johnson Professionals, Inc. | 2 | 1980-08-20 |
| Megadyne Medical Products, Inc. | 1 | 1993-12-23 |
| Medovations, Inc. | 1 | 1991-12-16 |
| Cook Urological, Inc. | 1 | 1991-03-28 |
| 3M Company | 1 | 1983-10-31 |
Most recent KGY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K933085 | Megadyne Medical Products, Inc. | GOODMAN BANDAGE | 1993-12-23 | 183 |
| K913678 | Medovations, Inc. | TROCAR CATHETER | 1991-12-16 | 119 |
| K910914 | Cook Urological, Inc. | SURGICAL TISSUE POUCH | 1991-03-28 | 23 |
| K832318 | 3M Company | ISOLATION BAG 3M | 1983-10-31 | 108 |
| K801824 | Johnson & Johnson Professionals, Inc. | BAND-AID BRAND FLEXIBLE FABRIC BANDAGE | 1980-08-20 | 20 |
Recalls for KGY devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2015-05-14.
Frequently asked questions
What is FDA product code KGY?
KGY is the FDA product code for bag, intestine. It is a Class I device, regulated under 21 CFR 878.4100 and reviewed by the General and Plastic Surgery panel.
What device class is KGY?
Class I, regulation 21 CFR 878.4100. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KGY?
Across 6 cleared submissions the average was 79 days from receipt to decision (median 66).
Which companies have the most KGY clearances?
Johnson & Johnson Professionals, Inc. (2); Megadyne Medical Products, Inc. (1); Medovations, Inc. (1); Cook Urological, Inc. (1); 3M Company (1).
Have KGY devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2015-05-14.
Next steps
- Run an FDA pathway report with predicate devices for product code KGY
- Run a recall and safety report across every KGY manufacturer
- Watch product code KGY for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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