ENDO SMARTCAP— 510(k) K093665

Clearance details

Applicant

Byrne Medical, Inc.

Product code

Code FAJ

Device class

Class 2

Regulation

21 CFR 876.1500

Advisory panel

Gastroenterology, Urology

Date received

2009-11-25

Decision date

2009-12-15

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Conroe, TX, US

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• K253905 — PrimeSight UltraView System2026-04-07
• K260271 — Strauss Surgical cystoscope, hysteroscope and accessories Instruments2026-03-27

• K113310 — ENDOGATER AVANTAGE CO2 INSUFFLATOR2012-06-20
• K113119 — ENDOGATOR ADVANTAGE IRRIGATION PUMP2012-04-27
• K102855 — UNIVERSAL IRRIGATION SOLUTION HYBRID2010-11-19
• K102581 — DEFENDO DISPOSABLE SUCTION VALVE MODEL 1003052010-11-08
• K102409 — DEFENDO DISPOSABLE AIR/WATER VALVE MODEL 1003042010-11-04

Injury

533

Malfunction

6,705

Total

7,238

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1772-2020 — Medivators Endo Smartcap Endoscope Tubing. REF100145. Packaged as Contents 1, 10, 50, and found in BMP-C145. Tubing for Olympus 140/240, 160/260, 180/280, 190/290 Series Endoscopes. Sterile EO - Product Usage: is intended to be used with an air or CO2 source and/or a pump along with a sterile water source to supply air or CO2 and sterile water to an endoscope during endoscopic procedures.Class II·Terminated·Medivators, Inc.·20191009
• Z-1773-2020 — Medivators Endo Smartcap Endoscope Tubing. REF100145CO2, packaged as Contents 1, 10, 50 and found in BMP-C145CO2. Tubing for Olympus 140/240, 160/260, 180/280, 190/290 Series Endoscopes. Sterile EO - Product Usage: is intended to be used with an air or CO2 source and/or a pump along with a sterile water source to supply air or CO2 and sterile water to an endoscope during endoscopic procedures.Class II·Terminated·Medivators, Inc.·20191009
• Z-1774-2020 — Medivators Endo Smartcap Endoscope Tubing. REF100145CO2EXTU, packaged as Contents 1, 10, 50. Tubing for Olympus 140/240, 160/260, 180/280, 190/290 Series Endoscopes With Extended CO2 Input. Sterile EO - Product Usage: is intended to be used with an air or CO2 source and/or a pump along with a sterile water source to supply air or CO2 and sterile water to an endoscope during endoscopic procedures.Class II·Terminated·Medivators, Inc.·20191009
• Z-1775-2020 — Medivators Endo Smartcap Endoscope Tubing. REF100145CO2EXT, packaged as Contents 1, 10, 50, and found in BMP-C145CO2EXT. Tubing for Olympus 140/240, 160/260, 180/280, 190/290 Series Endoscopes With Extended CO2 Input. Sterile EO - Product Usage: is intended to be used with an air or CO2 source and/or a pump along with a sterile water source to supply air or CO2 and sterile water to an endoscope during endoscopic procedures.Class II·Terminated·Medivators, Inc.·20191009
• Z-1776-2020 — Medivators EndoGator REF 100650. Kit for Olympus 140/160/180/190 Series GI Endoscopes forCO2 Connection with Olympus OFP or Boston Scientific Endostat II Irrigation Pump Units. Contents 10. Sterile EO. of 100145CO2EXT Endo SmartCap Irrigation Tubing for Olympus 140/240, 160/260, 180/280, 190/290 Series GI Endoscopes with Extended CO2 Input - Product Usage: is intended to be used with an air or CO2 source and/or a pump along with a sterile water source to supply air or CO2 and sterile water to an endoscope during endoscopic procedures.Class II·Terminated·Medivators, Inc.·20191009
• Z-1777-2020 — Medivators EndoGator REF 100651. Kit for Olympus 140/160/180/190 Series GI Endoscopes for CO2 Connection with Endogator EGP-100, Olympus OFP, Olympus AFU-100 & Erbe EIP 2 Irrigation Pump Units. Contents 10. Sterile EO. of 100145CO2EXT Endo SmartCap Irrigation Tubing for Olympus 140/160/180/190 Series GI Endoscopes with Extended CO2 Input - Product Usage: is intended to be used with an air or CO2 source and/or a pump along with a sterile water source to supply air or CO2 and sterile water to an endoscope during endoscopic procedures.Class II·Terminated·Medivators, Inc.·20191009
• Z-1778-2020 — Medivators Endo carry-on Procedure Kit REF CPK-100222-0002 - Product Usage: is intended to be used with an air or CO2 source and/or a pump along with a sterile water source to supply air or CO2 and sterile water to an endoscope during endoscopic procedures.Class II·Terminated·Medivators, Inc.·20191009

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K093665.