Panels › Gastroenterology, Urology › Product code PIF · Class 2
Gastrointestinal Tubes With Enteral Specific Connectors
Regulation 876.5980
3510(k)s in 12 months (52 all time)
1recalls in 12 months (112 all time)
111recalls that name a 510(k)
Top companies in PIF
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 11, 2026 | Boston Scientific Corporation EndoVive Safety PEG Kit;
Outer Box Material Number (UPN): M00509001;
Inner Box Material Number (UPN): M00509000; Open, Classified |
PIF | K150679 |
| Jan 7, 2025 | Applied Medical Technology Inc AMT Mini Enteral Extension Set, 12" Right Angle Feeding Set with Y-Port. Model/Catalog Number: E6-1222 Completed |
PIF | K142989 |
| Apr 11, 2024 | Boston Scientific Corporation EndoVive 20Fr Push Standard PEG Kit w/ENFit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who are unable to consume nutrition by conventional m Open, Classified |
PIF | K150679 |
| Apr 11, 2024 | Boston Scientific Corporation EndoVive 20Fr Push Safety PEG Kit w/ENFit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who are unable to consume nutrition by conventional mea Open, Classified |
PIF | K150679 |
| Feb 16, 2024 | Boston Scientific Corporation EndoVive Replacement Button Kit w/ ENFIT 28F 2.8 CM, Outer Box UPN M00509500 or M00509510. Open, Classified |
PIF | K161003 |
| Mar 20, 2019 | GETINGE US SALES LLC Maquet Servo-I Ventilator System -EDI CATHETER PHT Free 6Fr/49cm 5/pkg
Product Code/REF Number: 6685775
Product Usage: The Edi Catheter is a single-use naso-gastric feeding tube with an electrode ar Terminated |
PIF | K153688 |
| Dec 23, 2015 | Xeridiem Mediem Medical Devices Inc EndoVive 3s Low Profile Balloon Kits
Part Number:
M00549600
(XMD P/N 70-0050-G24)
The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for e Terminated |
PIF | K142297 |
| Dec 23, 2015 | Xeridiem Mediem Medical Devices Inc EndoVive 3s Low Profile Balloon Kits
Part Number:
M00549460
(XMD P/N 70-0050-G22)
The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for e Terminated |
PIF | K142297 |
| Dec 23, 2015 | Xeridiem Mediem Medical Devices Inc EndoVive 3s Low Profile Balloon Kits
Part Number:
M00548970
(XMD P/N 70-0050-G20)
The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for e Terminated |
PIF | K142297 |
| Dec 23, 2015 | Xeridiem Mediem Medical Devices Inc EndoVive 3s Low Profile Balloon Kits
Part Number:
M00548810
(XMD P/N 70-0050-G18)
The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for e Terminated |
PIF | K142297 |
| Dec 23, 2015 | Xeridiem Mediem Medical Devices Inc EndoVive 3s Low Profile Balloon Kits
Part Number:
M00548650
(XMD P/N 70-0050-G16)
The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for e Terminated |
PIF | K142297 |
| Dec 23, 2015 | Xeridiem Mediem Medical Devices Inc EndoVive 3s Low Profile Balloon Kits
Part Number:
M00548490
(XMD P/N 70-0050-G14)
The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for e Terminated |
PIF | K142297 |
| Dec 23, 2015 | Xeridiem Mediem Medical Devices Inc EndoVive 3s Low Profile Balloon Kits
Part Number:
M00549590
(XMD P/N 70-0050-F24)
The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for e Terminated |
PIF | K142297 |
| Dec 23, 2015 | Xeridiem Mediem Medical Devices Inc EndoVive 3s Low Profile Balloon Kits
Part Number:
M00549450
(XMD P/N 70-0050-F22)
The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for e Terminated |
PIF | K142297 |
| Dec 23, 2015 | Xeridiem Mediem Medical Devices Inc EndoVive 3s Low Profile Balloon Kits
Part Number:
M00548960
(XMD P/N 70-0050-F20)
The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for e Terminated |
PIF | K142297 |
| Dec 23, 2015 | Xeridiem Mediem Medical Devices Inc EndoVive 3s Low Profile Balloon Kits
Part Number:
M00548800
(XMD P/N 70-0050-F18)
The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for e Terminated |
PIF | K142297 |
| Dec 23, 2015 | Xeridiem Mediem Medical Devices Inc EndoVive 3s Low Profile Balloon Kits
Part Number:
M00548640
(XMD P/N 70-0050-F16)
The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for e Terminated |
PIF | K142297 |
| Dec 23, 2015 | Xeridiem Mediem Medical Devices Inc EndoVive 3s Low Profile Balloon Kits
Part Number:
M00548480
(XMD P/N 70-0050-F14)
The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for e Terminated |
PIF | K142297 |
| Dec 23, 2015 | Xeridiem Mediem Medical Devices Inc EndoVive 3s Low Profile Balloon Kits
Part Number:
M00549580
(XMD P/N 70-0050-E24)
The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for e Terminated |
PIF | K142297 |
| Dec 23, 2015 | Xeridiem Mediem Medical Devices Inc EndoVive 3s Low Profile Balloon Kits
Part Number:
M00549440
(XMD P/N 70-0050-E22)
The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for e Terminated |
PIF | K142297 |
| Dec 23, 2015 | Xeridiem Mediem Medical Devices Inc EndoVive 3s Low Profile Balloon Kits
Part Number:
M00548950
(XMD P/N 70-0050-E20)
The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for e Terminated |
PIF | K142297 |
| Dec 23, 2015 | Xeridiem Mediem Medical Devices Inc EndoVive 3s Low Profile Balloon Kits
Part Number:
M00548790
(XMD P/N 70-0050-E18)
The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for e Terminated |
PIF | K142297 |
| Dec 23, 2015 | Xeridiem Mediem Medical Devices Inc EndoVive 3s Low Profile Balloon Kits
Part Number:
M00548630
(XMD P/N 70-0050-E16)
The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for e Terminated |
PIF | K142297 |
| Dec 23, 2015 | Xeridiem Mediem Medical Devices Inc EndoVive 3s Low Profile Balloon Kits
Part Number:
M00548470
(XMD P/N 70-0050-E14)
The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for e Terminated |
PIF | K142297 |
| Dec 23, 2015 | Xeridiem Mediem Medical Devices Inc EndoVive 3s Low Profile Balloon Kits
Part Number:
M00549570
(XMD P/N 70-0050-D24)
The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for e Terminated |
PIF | K142297 |
| Dec 23, 2015 | Xeridiem Mediem Medical Devices Inc EndoVive 3s Low Profile Balloon Kits
Part Number:
M00549430
(XMD P/N 70-0050-D22)
The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for e Terminated |
PIF | K142297 |
| Dec 23, 2015 | Xeridiem Mediem Medical Devices Inc EndoVive 3s Low Profile Balloon Kits
Part Number:
M00548780
(XMD P/N 70-0050-D20)
The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for e Terminated |
PIF | K142297 |
| Dec 23, 2015 | Xeridiem Mediem Medical Devices Inc EndoVive 3s Low Profile Balloon Kits
Part Number:
M00548620
(XMD P/N 70-0050-D16)
The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for e Terminated |
PIF | K142297 |
| Dec 23, 2015 | Xeridiem Mediem Medical Devices Inc EndoVive 3s Low Profile Balloon Kits
Part Number:
M00548460
(XMD P/N 70-0050-D14)
The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for e Terminated |
PIF | K142297 |
| Dec 23, 2015 | Xeridiem Mediem Medical Devices Inc EndoVive 3s Low Profile Balloon Kits
Part Number:
M00549560
(XMD P/N 70-0050-C24)
The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for e Terminated |
PIF | K142297 |
| Dec 23, 2015 | Xeridiem Mediem Medical Devices Inc EndoVive 3s Low Profile Balloon Kits
Part Number:
M00549420
(XMD P/N 70-0050-C22)
The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for e Terminated |
PIF | K142297 |
| Dec 23, 2015 | Xeridiem Mediem Medical Devices Inc EndoVive 3s Low Profile Balloon Kits
Part Number:
M00548930
(XMD P/N 70-0050-C20)
The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for e Terminated |
PIF | K142297 |
| Dec 23, 2015 | Xeridiem Mediem Medical Devices Inc EndoVive 3s Low Profile Balloon Kits
Part Number:
M00548770
(XMD P/N 70-0050-C18)
The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for e Terminated |
PIF | K142297 |
| Dec 23, 2015 | Xeridiem Mediem Medical Devices Inc EndoVive 3s Low Profile Balloon Kits
Part Number:
M00548610
(XMD P/N 70-0050-C16)
The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for e Terminated |
PIF | K142297 |
| Dec 23, 2015 | Xeridiem Mediem Medical Devices Inc EndoVive 3s Low Profile Balloon Kits
Part Number:
M00548450
(XMD P/N 70-0050-C14)
The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for e Terminated |
PIF | K142297 |
| Dec 23, 2015 | Xeridiem Mediem Medical Devices Inc EndoVive 3s Low Profile Balloon Kits
Part Number:
M00549550
(XMD P/N 70-0050-B24)
The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for e Terminated |
PIF | K142297 |
| Dec 23, 2015 | Xeridiem Mediem Medical Devices Inc EndoVive 3s Low Profile Balloon Kits
Part Number:
M00549410
(XMD P/N 70-0050-B22)
The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for e Terminated |
PIF | K142297 |
| Dec 23, 2015 | Xeridiem Mediem Medical Devices Inc EndoVive 3s Low Profile Balloon Kits
Part Number:
M00548920
(XMD P/N 70-0050-B20)
The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for e Terminated |
PIF | K142297 |
| Dec 23, 2015 | Xeridiem Mediem Medical Devices Inc EndoVive 3s Low Profile Balloon Kits
Part Number:
M00548760
(XMD P/N 70-0050-B18)
The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for e Terminated |
PIF | K142297 |
| Dec 23, 2015 | Xeridiem Mediem Medical Devices Inc EndoVive 3s Low Profile Balloon Kits
Part Number:
M00548600
(XMD P/N 70-0050-B16)
The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for e Terminated |
PIF | K142297 |
| Dec 23, 2015 | Xeridiem Mediem Medical Devices Inc EndoVive 3s Low Profile Balloon Kits
Part Number:
M00548440
(XMD P/N 70-0050-B14)
The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for e Terminated |
PIF | K142297 |
| Dec 23, 2015 | Xeridiem Mediem Medical Devices Inc EndoVive 3s Low Profile Balloon Kits
Part Number:
M00548320
(XMD P/N 70-0050-B12)
The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for e Terminated |
PIF | K142297 |
| Dec 23, 2015 | Xeridiem Mediem Medical Devices Inc EndoVive 3s Low Profile Balloon Kits
Part Number:
M00549540
(XMD P/N 70-0050-A24)
The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for e Terminated |
PIF | K142297 |
| Dec 23, 2015 | Xeridiem Mediem Medical Devices Inc EndoVive 3s Low Profile Balloon Kits
Part Number:
M00549400
(XMD P/N 70-0050-A22)
The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for e Terminated |
PIF | K142297 |
| Dec 23, 2015 | Xeridiem Mediem Medical Devices Inc EndoVive 3s Low Profile Balloon Kits
Part Number:
M00548910
(XMD P/N 70-0050-A20)
The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for e Terminated |
PIF | K142297 |
| Dec 23, 2015 | Xeridiem Mediem Medical Devices Inc EndoVive 3s Low Profile Balloon Kits
Part Number:
M00548750
(XMD P/N 70-0050-A18) Terminated |
PIF | K142297 |
| Dec 23, 2015 | Xeridiem Mediem Medical Devices Inc EndoVive 3s Low Profile Balloon Kits
Part Number:
M00548590
(XMD P/N 70-0050-A16)
The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for e Terminated |
PIF | K142297 |
| Dec 23, 2015 | Xeridiem Mediem Medical Devices Inc EndoVive 3s Low Profile Balloon Kits
Part Number
M00548430
(XMD P/N 70-0050-A14)
The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for en Terminated |
PIF | K142297 |
| Dec 23, 2015 | Xeridiem Mediem Medical Devices Inc EndoVive 3s Low Profile Balloon Kits
Part Number:
M00548310
(XMD P/N 70-0050-A12)
The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for e Terminated |
PIF | K142297 |
| Dec 23, 2015 | Xeridiem Mediem Medical Devices Inc EndoVive 3s Low Profile Balloon Kits
Part Number:
M00549530
(XMD P/N 70-0050-924)
The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for e Terminated |
PIF | K142297 |
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