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Panels › Gastroenterology, Urology › Product code FED · Class 2

Endoscopic Access Overtube, Gastroenterology-Urology

Regulation 876.1500

6510(k)s in 12 months (105 all time)
0recalls in 12 months (12 all time)
9recalls that name a 510(k)
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Top companies in FED

Company510(k)sRecalls
Boston Scientific73
Usgi Medical60
Boddingtons Plastics, Ltd.41
C.R. Bard, Inc.50
Neptune Medical, Inc.50
Trokamed GmbH14
Coloplast A/S40
United States Endoscopy Group, Inc.40
Applied Medical Resources30
Calyxo, Inc.21
DateFirm and productCodeLinked 510(k)
Mar 21, 2025Calyxo, Inc.
CVAC Aspiration System, REF: CVC127020-1, and User Manual L00018. Intended for endoscopic examination/treatment of urinary tract and kidney interior.
Open, Classified		 FEDK233472
Jan 10, 2025Trokamed GmbH
Sheath, 18 Fr., 160 mm (REF: WA2PS18L), gastroenterology-urology endoscopic access overtube.
Open, Classified		 FEDK200770
Jan 10, 2025Trokamed GmbH
Sheath, 18 Fr., 130 mm (REF: WA2PS18S), gastroenterology-urology endoscopic access overtube.
Open, Classified		 FEDK200770
Jan 10, 2025Trokamed GmbH
Sheath, 20 Fr., 160 mm (REF: WA2PS20L), gastroenterology-urology endoscopic access overtube.
Open, Classified		 FEDK200770
Jan 10, 2025Trokamed GmbH
Sheath, 20 Fr., 130 mm (REF: WA2PS20S), gastroenterology-urology endoscopic access overtube.
Open, Classified		 FEDK200770
Aug 3, 2021Olympus Corporation of the Americas
Arc Endocuff Vision as follows: ARV110 ENDOCUFF-V M BLUE PK8, Part Number: E0420501; ARV120 ENDOCUFF-V L GREEN PK8, Part Number: E0420500; ARV130 ENDOCUFF-V S PURPLE PK8, Part Number: E0420502; AR
Terminated		 FEDK151801
Mar 11, 2020Boddingtons Plastics Ltd
Endocuff Vision: models ARV 110, 120, 130, 140 Intended Use: ENDOCUFF VISION is a device attached to the distal end of a colonoscope, designed to maintain and maximize the viewable mucosa during end
Terminated		 FEDK151801
Dec 4, 2013Boston Scientific Corporation
Navigator HD l3F/15F x 46cm Ureteral Access Sheath Set Product No M0062502280, RDF Catalog M0062502290, Sterile. Indicated for use in endoscopic procedures to facilitate the passage of endoscopes, u
Terminated		 FEDNone listed
Dec 4, 2013Boston Scientific Corporation
Navigator HD l3F/15F x 36cm Ureteral Access Sheath Set Product No M0062502280, RDF Catalog No 250-228, Sterile. Indicated for use in endoscopic procedures to facilitate the passage of endoscopes, ur
Terminated		 FEDNone listed
Dec 4, 2013Boston Scientific Corporation
Navigator HD l3F/15F x 28 cm Ureteral Access Sheath Set Product No M0062502270, RDF Catalog No 250-227, Sterile. Indicated for use in endoscopic procedures to facilitate the passage of endoscopes, u
Terminated		 FEDNone listed
Jan 25, 2007Cook Urological, Inc.
Cook Flexor DL Dual Lumen Ureteral Access Sheath with AQ Coating, sterile, REF FUS-095013-DL.
Terminated		 FEDK043418
Jul 20, 2004Medtronic Xomed, Inc.
The product is a sheath meant to fit over a Nasopharyngoscope and is labeled as EndoScrub 2 Sheaths
Terminated		 FEDK982594

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