510(k) K962652 ยท KNX Collector, Urine, (And Accessories) For Indwelling Catheter
URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749)
| Applicant | Customed, Inc., Fajardo PR, US |
| Decision | Substantially Equivalent, Oct 4, 1996 |
| Received | Jul 8, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K962652
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 14, 2016 | Customed, Inc Catalog Number: 9001127 FOLEY CATHETER TRAY 16 FR-5CC- 2WAY SILICONE COATED FOLEY
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture remov Terminated |
NWR | None listed |
| Apr 14, 2016 | Customed, Inc Catalog Number: 9001139 FOLEY CATHETER TRAY 18 FR -5CC-2WAY SILICONE COATED FOLEY
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture remov Terminated |
NWR | None listed |
| Apr 14, 2016 | Customed, Inc Catalog Number: 9001460
REYITO PLUS UROLOGY SURGICAL PACK
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, e Terminated |
LRO | None listed |
| Apr 14, 2016 | Customed, Inc Catalog Number: 9001521
UROLOGY SURGICAL PACK
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
LRO | None listed |
| Apr 14, 2016 | Customed, Inc Catalog Number: 9001738
UROLOGY SURGICAL PACK
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
LRO | None listed |
| Sep 3, 2015 | Customed, Inc FOLEY CATHETER KIT II 16FR. CUSTOMED 20/CS
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
. Terminated |
NWR | None listed |
| Sep 3, 2015 | Customed, Inc FOLEY CATHETER KIT II 18 FR 20/CS
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
. Terminated |
NWR | None listed |
| Sep 3, 2015 | Customed, Inc UROLOGY CUSTOMED PACK 5/CS
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
. Terminated |
KNX | None listed |
| Sep 3, 2015 | Customed, Inc FOLEY CATH KIT 16FR. W/FOLEY S SENSOR 20/CS
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
. Terminated |
KNX | None listed |
| Sep 3, 2015 | Customed, Inc UROLOGY PACK 4/CS
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
. Terminated |
KNX | None listed |
| Sep 3, 2015 | Customed, Inc UROLOGY PK 5/CS
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
. Terminated |
KNX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.