ONE STEP BUTTON(TM)
FDA 510(k) clearance K910584 · decided 1991-05-23
Clearance details
- K-number
- K910584
- Device name
- ONE STEP BUTTON(TM)
- Applicant
- Applied Medical Technologies
- Decision
- Substantially Equivalent
- Date received
- 1991-02-11
- Decision date
- 1991-05-23
- Days to decision
- 101 days
- Clearance type
- Traditional
- Product code
- KGC
- Device class
- 2
- Regulation number
- 876.5980
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Independence, OH, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Applied Medical Technologies
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PUMA-G Pediatric System (K242211) | Coaptech, Inc. | 2025-04-29 |
| PUMA-G System (K223916) | Coaptech, Inc. | 2023-03-29 |
| AMT Suture Delivery System (K193612) | Applied Medical Technology, Inc. | 2020-03-12 |
| Fidmi Low Profile Enteral Feeding Device (K191844) | Fidmi Medical, Ltd. | 2019-09-30 |
| Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor Set (K182832) | Cook Incorporated | 2019-06-26 |
| PUMA-G System (K183057) | Coaptech, LLC | 2019-04-10 |
| Entuit Start Initial Placement Gastrostomy Set (K170323) | Cook Incorporated | 2017-09-14 |
| AMT T-FASTENER ANCHOR KIT (K120587) | Applied Medical Technology, Inc. | 2012-05-25 |
| KIMBERLY-CLARK GASTROINTESTINAL ANCHOR SET WITH SAF-T-PEXY FASTENERS, ENTERNAL ACCESS DILATION SYSTEM (K093312) | Kimberly-Clark Corp. | 2009-12-08 |
| MEDLINE GASTROSTOMY TUBE (K073718) | Medline Industries, Inc. | 2008-03-19 |
| KIMBERLY-CLARK INTRODUCER KITS (K080253) | Kimberly-Clark Corp. | 2008-02-26 |
| AMT DECOMPRESSION TUBES (K980145) | Applied Medical Technology, Inc. | 1998-04-10 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| One Step Button, Low Profile Initial Placement PEG Kit, gastro-enterostomy tube. recall (Z-0402-2016) | Boston Scientific Corp | 2015-12-10 |
| Boston Scientific brand Low Profile PEG (percutaneous endoscopic gastrostomy tubes) Kit, 1 recall (Z-0962-05) | Boston Scientific Corp | 2005-07-07 |
| Boston Scientific brand One Step Button (percutaneous endoscopic gastrostomy tubes) Kit, 1 recall (Z-0969-05) | Boston Scientific Corp | 2005-07-07 |
| Boston Scientific brand One Step Button (percutaneous endoscopic gastrostomy tubes) Kit, 2 recall (Z-0970-05) | Boston Scientific Corp | 2005-07-07 |
| Boston Scientific brand One Step Button (percutaneous endoscopic gastrostomy tubes) Kit, 2 recall (Z-0971-05) | Boston Scientific Corp | 2005-07-07 |
| Boston Scientific brand One Step Button (percutaneous endoscopic gastrostomy tubes) Kit, 2 recall (Z-0972-05) | Boston Scientific Corp | 2005-07-07 |