Amt T-Fastener Anchor Kit
FDA 510(k) K120587 · Applied Medical Technology, Inc.
510(k) numberK120587
Submission
- Device name
- Amt T-Fastener Anchor Kit
- Applicant
- Applied Medical Technology, Inc.
Brecksville, OH, US - Received
- February 27, 2012
- Decision date
- May 25, 2012
- Decision
- Unknown (SESK)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KGC – Tube, Gastro-Enterostomy
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5980
- Specialty
- Gastroenterology, Urology
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| K223916 | PUMA-G SystemKGC · Traditional | Coaptech, Inc. | 03/29/2023SE |
| K193612 | AMT Suture Delivery SystemKGC · Traditional | Applied Medical Technology, Inc. | 03/12/2020SE |
| K191844 | Fidmi Low Profile Enteral Feeding DeviceKGC · Traditional | Fidmi Medical, Ltd. | 09/30/2019SE |
| K182832 | Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor SetKGC · Traditional | Cook Incorporated | 06/26/2019SESK |
| K183057 | PUMA-G SystemKGC · Traditional | Coaptech, LLC | 04/10/2019SE |
| K170323 | Entuit Start Initial Placement Gastrostomy SetKGC · Traditional | Cook Incorporated | 09/14/2017SE |
| K093312 | Kimberly-Clark Gastrointestinal Anchor Set with Saf-T-Pexy Fasteners, Enternal Access…KGC · Special | Kimberly-Clark Corp. | 12/08/2009SE |
| K073718 | Medline Gastrostomy TubeKGC · Abbreviated | Medline Industries, Inc. | 03/19/2008SE |
| K080253 | Kimberly-Clark Introducer KitsKGC · Special | Kimberly-Clark Corp. | 02/26/2008SESK |
More from Kimberly-Clark Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K252438 | Explant ExpressQVS · Traditional | 02/03/2026SE |
| K240514 | AMT Low-Profile Suprapubic Catheter & Drainage SetKOB · Traditional | 11/01/2024SE |
| K241111 | AMT Suture PasserGCJ · Traditional | 07/05/2024SE |
| K222846 | AMT G-Tube Balloon Gastrostomy Feeding DeviceKNT · Traditional | 12/18/2023SE |
| K202539 | Nutriglide(TM) Nasal Feeding TubeKNT · Traditional | 10/29/2020SE |
| K193612 | AMT Suture Delivery SystemKGC · Traditional | 03/12/2020SE |
| K183508 | Micro Transgastric-Jejunal Feeding DeviceKNT · Traditional | 03/29/2019SESK |
| K182804 | Traditional Length GJ Feeding DeviceKNT · Traditional | 03/01/2019SE |
| K180026 | Bowel Management Device, Bowel Management Irrigation SetKNT · Traditional | 06/01/2018SESK |
| K170319 | Low Profile Non-Balloon Feeding DeviceKNT · Traditional | 10/06/2017SE |
Questions and answers
When was Amt T-Fastener Anchor Kit cleared by the FDA?
Amt T-Fastener Anchor Kit (K120587) received a 510(k) decision of Unknown on May 25, 2012, 88 days after the submission was received.
What is the product code of K120587?
The FDA product code is KGC – Tube, Gastro-Enterostomy, a Class II (moderate risk) device regulated under 21 CFR 876.5980.