510(k) K980145
- Device
- AMT DECOMPRESSION TUBES
- Applicant
- APPLIED MEDICAL TECHNOLOGY, INC.
- 510(k) number
- K980145
- Product code
- KGC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-04-10
- Date received
- 1998-01-15
- Regulation
- 876.5980
- Classification name
- Tube, Gastro-enterostomy
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- THOMAS W PARKINSON
- Address
- 15653 Neo Pkwy. Cleveland OH US 44128 44128
FDA Registration Numbers#
- 1064858
- 1526012
- 2527072
- 3009888344
- 3011270181
- 2528981
- 3008717566
- 9611594
- 3015259858
- 3007289408
- 3010273872
- 3005099803
- 3005636544
- 1625425
- 1417592
- 1644312
- 3015177732
- 1000393132
- 3006260740
- 1643817
- 2031093
- 1820334
- 1048735
- 3012494290
- 3018507299
- 3003915875
Source Documents#
Other 510(k) Records For Product Code KGC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K242211 | PUMA-G Pediatric System | Coaptech, Inc. | 2025-04-29 |
| K223916 | PUMA-G System | Coaptech, Inc. | 2023-03-29 |
| K193612 | AMT Suture Delivery System | Applied Medical Technology, Inc. | 2020-03-12 |
| K191844 | Fidmi Low Profile Enteral Feeding Device | Fidmi Medical, Ltd. | 2019-09-30 |
| K182832 | Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor Set | Cook Incorporated | 2019-06-26 |
| K183057 | PUMA-G System | Coaptech, LLC | 2019-04-10 |
| K170323 | Entuit Start Initial Placement Gastrostomy Set | Cook Incorporated | 2017-09-14 |
| K120587 | AMT T-FASTENER ANCHOR KIT | Applied Medical Technology, Inc. | 2012-05-25 |
| K093312 | KIMBERLY-CLARK GASTROINTESTINAL ANCHOR SET WITH SAF-T-PEXY FASTENERS, ENTERNAL ACCESS DILATION SYSTEM | Kimberly-Clark Corp. | 2009-12-08 |
| K073718 | MEDLINE GASTROSTOMY TUBE | Medline Industries, Inc. | 2008-03-19 |
| K080253 | KIMBERLY-CLARK INTRODUCER KITS | Kimberly-Clark Corp. | 2008-02-26 |
| K910492 | BARD REPLACEMENT GASTROSTOMY TUBE | C.R. Bard, Inc. | 1991-07-24 |
| K910584 | ONE STEP BUTTON(TM) | Applied Medical Technologies | 1991-05-23 |
| K904779 | BUTTON REPLACEMENT GASTROSTOMY DEVICE | C.R. Bard, Inc. | 1991-01-18 |
| K904801 | ORION LIFE SYSTEMS REPLACEMENT GASTROSTOMY TUBE | Orion Life Systems, Inc. | 1991-01-16 |
Legacy Summary#
summary
FDA Review#
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