510(k) K031538 ยท KNT Tubes, Gastrointestinal (And Accessories)
ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, AND PEG SAFETY KIT
| Applicant | Boston Scientific Corp, Natick, MA, US |
| Decision | Substantially Equivalent, Jun 27, 2003 |
| Received | May 16, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K031538
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 11, 2024 | Boston Scientific Corporation EndoVive 20Fr Push Safety PEG Kit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who are unable to consume nutrition by conventional means.
UPN: Open, Classified |
KNT | None listed |
| Apr 11, 2024 | Boston Scientific Corporation EndoVive 20Fr Push Standard PEG Kit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who are unable to consume nutrition by conventional means.
UP Open, Classified |
KNT | None listed |
| Apr 11, 2024 | Boston Scientific Corporation EndoVive 20 Fr Safety PEG Push w/ENFit Kit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who are unable to consume nutrition by conventional me Open, Classified |
KNT | None listed |
| May 5, 2009 | Boston Scientific Corp Boston Scientific EndoVive 20F (6.7 mm) Safety PEG Kit, Push Method for use with sterile Xylocaine ampule, latex free, sterile, Boston Scientific Corp., Natick, MA; Cat. no./REF 6647, inner pouch UPN Terminated |
KNT | None listed |
| May 5, 2009 | Boston Scientific Corp Boston Scientific EndoVive 24F (8 mm) Safety PEG Kit, Push Method for use with sterile Xylocaine ampule, latex free, sterile, Boston Scientific Corp., Natick, MA; Cat. no./REF 6649, inner pouch UPN M0 Terminated |
KNT | None listed |
| May 5, 2009 | Boston Scientific Corp Boston Scientific EndoVive 20Fr (6.7 mm) Safety PEG Kit, Push Method, latex free, sterile, Boston Scientific Corp., Natick, MA; Cat. no./REF 6653, inner pouch UPN M00566530 and outer carton UPN M00566 Terminated |
KNT | None listed |
| May 5, 2009 | Boston Scientific Corp Boston Scientific EndoVive 20Fr (6.7 mm) Safety PEG Kit, Push Method, for use with pre-filled lidocaine syringe, latex free, sterile, Boston Scientific Corp., Natick, MA; Cat. no./REF 6673, inner pouc Terminated |
KNT | None listed |
| May 5, 2009 | Boston Scientific Corp Boston Scientific EndoVive 20Fr (8 mm) Safety PEG Kit, Push Method, for use with pre-filled lidocaine syringe, latex free, sterile, Boston Scientific Corp., Natick, MA; Cat. no./REF 6675, inner pouch Terminated |
KNT | None listed |
| May 5, 2009 | Boston Scientific Corp Boston Scientific EndoVive 20F (6.7 mm) Standard PEG Kit, Push Method, latex free, sterile, Boston Scientific Corp., Natick, MA; Cat. no./REF 6821, inner pouch UPN M00568210 and outer carton UPN M0056 Terminated |
KNT | None listed |
| May 5, 2009 | Boston Scientific Corp Boston Scientific EndoVive 24F (8 mm) Standard PEG Kit, Push Method, latex free, sterile, Boston Scientific Corp., Natick, MA; inner pouch UPN M00568250 and outer carton UPN M00568251.
The devices a Terminated |
KNT | None listed |
| May 5, 2009 | Boston Scientific Corp Boston Scientific EndoVive 20F (6.7 mm) Standard PEG Kit, latex free, sterile, Boston Scientific Corp., Natick, MA; Cat. no./REF 6840, inner pouch UPN M00568400 and outer carton UPN M00568401.
The d Terminated |
KNT | None listed |
| Jan 28, 2009 | Boston Scientific Corp Boston Scientific EndoVive 20F (6.7 mm) Safety PEG Kit, Push Method for use with sterile Xylocaine ampule, latex free, sterile, Boston Scientific Corp., Natick, MA; Cat. no./REF 6647, inner pouch UPN Terminated |
KNT | None listed |
| Jan 28, 2009 | Boston Scientific Corp Boston Scientific EndoVive 24F (8 mm) Safety PEG Kit, Push Method for use with sterile Xylocaine ampule, latex free, sterile, Boston Scientific Corp., Natick, MA; Cat. no./REF 6649, inner pouch UPN M0 Terminated |
KNT | None listed |
| Jan 28, 2009 | Boston Scientific Corp Boston Scientific EndoVive 20Fr (6.7 mm) Safety PEG Kit, Push Method, latex free, sterile, Boston Scientific Corp., Natick, MA; Cat. no./REF 6653, inner pouch UPN M00566530 and outer carton UPN M00566 Terminated |
KNT | None listed |
| Jan 28, 2009 | Boston Scientific Corp Boston Scientific EndoVive 20F (6.7 mm) Safety PEG Kit, Push Method for use with pre-filled lidocaine syringe, latex free, sterile, Boston Scientific Corp., Natick, MA; Cat. no./REF 6673, inner pouch Terminated |
KNT | None listed |
| Jul 7, 2005 | Boston Scientific Corp Boston Scientific brand Standard PEG (percutaneous endoscopic gastrostomy tubes) Kit, 20 Fr, pull; catalog number 6820. Terminated |
KGC | None listed |
| Jul 7, 2005 | Boston Scientific Corp Boston Scientific brand Standard PEG (percutaneous endoscopic gastrostomy tubes) Kit, 20 Fr, push; catalog number 6821. Terminated |
KGC | None listed |
| Jul 7, 2005 | Boston Scientific Corp Boston Scientific brand Standard PEG (percutaneous endoscopic gastrostomy tubes) Kit, 24 Fr, pull; catalog number 6824. Terminated |
KGC | None listed |
| Jul 7, 2005 | Boston Scientific Corp Boston Scientific brand Standard PEG (percutaneous endoscopic gastrostomy tubes) Kit, 24 Fr, push; catalog number 6825. Terminated |
KGC | None listed |
| Jul 7, 2005 | Boston Scientific Corp Boston Scientific brand pull Gastro-dome (percutaneous endoscopic gastrostomy tubes) Kit, 20 Frl; catalog number 6838. Terminated |
KNT | None listed |
| Jul 7, 2005 | Boston Scientific Corp Boston Scientific brand pull Gastro-dome (percutaneous endoscopic gastrostomy tubes) Kit, 24 Frl; catalog number 6839. Terminated |
KNT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.