FDA product code KGC: Tube, Gastro-Enterostomy
KGC is the FDA product code for tube, gastro-enterostomy. It is a Class II device, regulated under 21 CFR 876.5980 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 26 510(k) submissions under KGC, 2 in the last five years, from 17 different applicants. The average 510(k) review took 114 days (median 89); 274 days on average over the last three years. FDA has posted 25 recalls for KGC devices.
Classification
| Field | Value |
|---|---|
| Device name | Tube, Gastro-Enterostomy |
| Device class | Class II |
| Regulation | 21 CFR 876.5980 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for KGC
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 225 |
| 2019 | 3 | 167 |
| 2020 | 1 | 77 |
| 2023 | 1 | 90 |
| 2025 | 1 | 274 |
Compare with all 510(k) review times · Search every KGC clearance
Top KGC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Applied Medical Technology, Inc. | 3 | 2020-03-12 |
| Applied Medical Technologies | 3 | 1991-05-23 |
| Coaptech, Inc. | 2 | 2025-04-29 |
| Cook Incorporated | 2 | 2019-06-26 |
| Kimberly-Clark Corp. | 2 | 2009-12-08 |
12 more applicants have KGC clearances. See the full list in Caduvo.
Most recent KGC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K242211 | Coaptech, Inc. | PUMA-G Pediatric System | 2025-04-29 | 274 |
| K223916 | Coaptech, Inc. | PUMA-G System | 2023-03-29 | 90 |
| K193612 | Applied Medical Technology, Inc. | AMT Suture Delivery System | 2020-03-12 | 77 |
| K191844 | Fidmi Medical, Ltd. | Fidmi Low Profile Enteral Feeding Device | 2019-09-30 | 83 |
| K182832 | Cook Incorporated | Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor Set | 2019-06-26 | 260 |
Recalls for KGC devices
25 product recalls in 5 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2015-09-11.
Frequently asked questions
What is FDA product code KGC?
KGC is the FDA product code for tube, gastro-enterostomy. It is a Class II device, regulated under 21 CFR 876.5980 and reviewed by the Gastroenterology and Urology panel.
What device class is KGC?
Class II, regulation 21 CFR 876.5980. Typical premarket route: 510(k).
How long does a 510(k) take for product code KGC?
Across 26 cleared submissions the average was 114 days from receipt to decision (median 89).
Which companies have the most KGC clearances?
Applied Medical Technology, Inc. (3); Applied Medical Technologies (3); Coaptech, Inc. (2); Cook Incorporated (2); Kimberly-Clark Corp. (2).
Have KGC devices been recalled?
Yes: 25 product recalls across 5 recall events; the most recent began 2015-09-11.
Next steps
- Run an FDA pathway report with predicate devices for product code KGC
- Run a recall and safety report across every KGC manufacturer
- Watch product code KGC 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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