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

Ureteroscope And Accessories, Flexible/Rigid

Regulation 876.1500

12510(k)s in 12 months (120 all time)

1recalls in 12 months (28 all time)

26recalls that name a 510(k)

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Top companies in FGB

Company	510(k)s	Recalls
Karl Storz Endoscopy	2	18
Boston Scientific Corporation	6	1
KARL STORZ Endoscopy-America, Inc.	7	0
Shanghai AnQing Medical Instrument Co., Ltd.	6	0
C.R. Bard, Inc.	5	0
Hunan Vathin Medical Instrument Co., Ltd.	5	0
Richard Wolf Medical Instruments Corp.	5	0
Circon Video	4	0
Karl Storz SE & CO. KG	4	0
Olympus Corporation of the Americas	0	4

Date	Firm and product	Code	Linked 510(k)
Sep 16, 2026	Boston Scientific Corporation Boston Scientific Corporation StoneSmart Connect Console Contents: (1) Power Cord, (1) Power Adaptor, (1)DVI Cable, (1) DVI to HDMI Cable, (1) DisplayPort Cable REF: M0067933000, M006793300H0, M006793 Open, Classified	FGB	K233645
Jan 30, 2025	Karl Storz Endoscopy KARL STORZ - ENDOSKOPE, REF: 27011K, Ureteroscope, 8 Fr., 6, 34cm, CE 0123 Open, Classified	FGB	K233372
Jan 30, 2025	Karl Storz Endoscopy KARL STORZ - ENDOSKOPE, REF: 27002K, Ureteroscope, 9.5 Fr., 6, 34 cm, NON STERILE, RxONLY, CE 0123 Open, Classified	FGB	K233372
Jan 30, 2025	Karl Storz Endoscopy KARL STORZ - ENDOSKOPE, REF: 27001K, Ureteroscope, 9.5 Fr., 6, 34 cm, NON STERILE, RxONLY, CE 0123 Open, Classified	FGB	K233372
Jan 30, 2025	Karl Storz Endoscopy KARL STORZ - ENDOSKOPE, REF: 27000K, Ureteroscope, 7 Fr., 6, 34 cm, NON STERILE, RxONLY, CE 0123 Open, Classified	FGB	K233372
Jan 30, 2025	Karl Storz Endoscopy KARL STORZ - ENDOSKOPE, REF: 27010K, Ureteroscope, 7 Fr., 34 cm, NON STERILE, RxONLY, CE 0123 Open, Classified	FGB	K233372
Jan 30, 2025	Karl Storz Endoscopy KARL STORZ - ENDOSKOPE, REF: 27002L, Uretero-Renoscope, 9.5 Fr., 6, 43 cm, NON STERILE, RxONLY, CE 0123 Open, Classified	FGB	K233372
Jan 30, 2025	Karl Storz Endoscopy KARL STORZ - ENDOSKOPE, REF: 27011L, Uretero-Renoscope, 8 Fr., 6, 43cm, NON STERILE, RxONLY, CE 0123 Open, Classified	FGB	K233372
Jan 30, 2025	Karl Storz Endoscopy KARL STORZ - ENDOSKOPE, REF: 27001L, Uretero-Renoscope, 8 Fr., 6, 43 cm, NON STERILE, RxONLY, CE 0123 Open, Classified	FGB	K233372
Jan 30, 2025	Karl Storz Endoscopy KARL STORZ - ENDOSKOPE, REF: 27000L,Uretero-Renoscope, 7 Fr., 6, 43 cm, NON STERILE, RxONLY, CE 0123 Open, Classified	FGB	K233372
Jan 30, 2025	Karl Storz Endoscopy KARL STORZ - ENDOSKOPE, REF: 27010L, Uretero-Renoscope, 7 Fr., 43cm, NON STERILE, RxONLY, CE 0123 Open, Classified	FGB	K233372
Jan 30, 2025	Karl Storz Endoscopy KARL STORZ - ENDOSKOPE, REF: 27002KP, Pediatric Uretero-Renoscope 7.3 Fr., NON STERILE, CE 0123 Open, Classified	FGB	K233372
Jan 30, 2025	Karl Storz Endoscopy KARL STORZ - ENDOSKOPE, REF: 27030KB, Pediatric Cysto-Urethroscope, NON STERILE, CE Open, Classified	FGB	K233372
Jan 30, 2025	Karl Storz Endoscopy KARL STORZ - ENDOSKOPE, REF: 27030KA, Cysto-Urethroscope, NON STERILE, CE Open, Classified	FGB	K233372
Jan 30, 2025	Karl Storz Endoscopy KARL STORZ - ENDOSKOPE, REF: 27003L, MICHEL Uretero-Renoscope, 9.5 Fr., 43cm, RxONLY, CE0123 Open, Classified	FGB	K233372
Oct 10, 2024	AURIS HEALTH INC Monarch Platform (Urology), REF: MON-000007, MON-000007-RFB Open, Classified	FGB	K213334
Nov 17, 2023	Aizu Olympus Co., Ltd. Uretero-reno fiberscope-For endoscopic diagnosis and treatment within the ureter and kidney. Model Numbers: URF-P7, URF-P7R, URF-V2, URF-V2R, URF-V3, URF-V3R. Open, Classified	FGB	K172246 K181451
Apr 20, 2022	Olympus Corporation of the Americas Olympus URETERO-RENO FIBERSCOPE Model: URF-P6R Open, Classified	FGB	K172298
Apr 20, 2022	Olympus Corporation of the Americas Olympus URETERO-RENO FIBERSCOPE Model: URF-P6 Open, Classified	FGB	K172298
Apr 1, 2022	Karl Storz Endoscopy 11278VSA 11278VSAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020); 11278VSE 11278VSEK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020); 11278VSU 11278VSUK Flexible Vi Open, Classified	FGB	K141250
Apr 1, 2022	Karl Storz Endoscopy 11278VSA 11278VSAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020); 11278VSE 11278VSEK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020); 11278VSU 11278VSUK Flexible Vi Open, Classified	FGB	K141250
Apr 1, 2022	Karl Storz Endoscopy 11278V 11278VK CMOS Video Ureteroscope Z17744US-A (04/2016); 11278VA 11278VAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020); 11278VU 11278VUK Flexible Video-Uretero-Renoscope (FLEX- Open, Classified	FGB	K131369
Apr 1, 2022	Karl Storz Endoscopy 11278A2 11278AK2 Flexible Ureteroscope Z20615US-BA (08-2018); 11278AC1 N/A Flexible Ureteroscope Z17859US-A (04/2016); 11278AC2 11278ACK2 Flexible Ureteroscope Z20615US-BA (08-2018); 11278ACU1 11278AC Open, Classified	FGB	K982905
Jan 17, 2018	Olympus Corporation of the Americas Uretero-reno fiberscope URF-P6RP6 Terminated	FGB	K172298
Jan 17, 2018	Olympus Corporation of the Americas Uretero-reno fiberscope URF-P6 Terminated	FGB	K172298
Jun 28, 2016	Pentax Medical Company Small Bowel Scope Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Esophagus, Stomach and Duodenum. The instrument is introduced via the mou Terminated	FGB	None listed
Jun 28, 2016	Pentax Medical Company Esophagoscope Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Esophagus, Stomach and Duodenum. The instrument is introduced via the mouth w Terminated	FGB	None listed
Jun 28, 2016	Pentax Medical Company Ureteroscope Intended to provide optical visualization of and therapeutic access to the Urinary Track. This anatomy includes but is not restricted to the organs, tissues and subsystems: Urethra, Bladd Terminated	FGB	K914106

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