Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor Set
FDA 510(k) clearance K182832 · decided 2019-06-26
Clearance details
- K-number
- K182832
- Device name
- Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor Set
- Applicant
- Cook Incorporated
- Decision
- Unknown
- Date received
- 2018-10-09
- Decision date
- 2019-06-26
- Days to decision
- 260 days
- Clearance type
- Traditional
- Product code
- KGC
- Device class
- 2
- Regulation number
- 876.5980
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Bloomington, IN, US
- Third-party review
- No
- Expedited review
- No
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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 |
| 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 |
| BARD REPLACEMENT GASTROSTOMY TUBE (K910492) | C.R. Bard, Inc. | 1991-07-24 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| COOK CHORIONIC VILLUS SAMPLING SET (P900007/S005) | Cook Incorporated | 2009-04-02 |
| COOK CHORIONIC VILLUS SAMPLING SET (P900007/S006) | Cook Incorporated | 2009-03-05 |
| COOK CHORIONIC VILLUS SAMPLING SET (P900007/S004) | Cook Incorporated | 2008-05-08 |
| COOK CHORIONIC VILLUS SAMPLING (CVS) SET (P900007/S002) | Cook Incorporated | 2000-06-12 |
| COOK CHORIONIC VILLUS SAMPLING SET (P900007/S001) | Cook Incorporated | 1998-07-08 |
| COOK CHORIONIC VILLUS SAMPLING SET (P900007) | Cook Incorporated | 1994-09-30 |