Atlas FDA

IMAGER II UROLOGY TORQUE CATHETER (C1 TIP); IMAGER II UROLOGY TORQUE CATHETER (C2 TIP; IMAGER II UROLOGY TORQUE CATHETER

FDA 510(k) clearance K102527 · decided 2010-11-05

Clearance details

K-number
K102527
Device name
IMAGER II UROLOGY TORQUE CATHETER (C1 TIP); IMAGER II UROLOGY TORQUE CATHETER (C2 TIP; IMAGER II UROLOGY TORQUE CATHETER
Applicant
Boston Scientific Corporation
Decision
Substantially Equivalent
Date received
2010-09-02
Decision date
2010-11-05
Days to decision
64 days
Clearance type
Traditional
Product code
KOD
Device class
2
Regulation number
876.5130
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Marlboro, MA, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Boston Scientific Corporation

The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Rubber Utility Catheter (K251864)C.R. Bard, Inc.2026-02-23
Wellead Ureteral Catheter (K220036)Well Lead Medical Co., Ltd.2022-12-16
allFlex Ureteral Catheters, Krait Ureteral Catheters (K220730)Allwin Medical Devices, Inc.2022-10-13
Urinary Catheter 12 Fr, Urinary Catheter 16 Fr (K211032)Urogen Pharma, Ltd.2021-11-19
Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter (K181979)Teleflexmedical, Inc.2019-05-24
UroGen Ureteral Catheter (K180354)Urogen Pharma, Ltd.2018-10-30
Angled Tip Ureteral Catheter (K181144)Cook Incorporated2018-06-28
Imager II Urology Torque Catheter (K180530)Boston Scientific Corporation2018-04-10
Cone Tip Ureteral Catheter, Rutner Universal Wedge Catheter (K171810)Cook Incorporated2018-03-07
Renal Access Cobra Catheter, Kumpe Access Catheter (K171600)Cook Incorporated2018-02-16
Open-End Ureteral Catheter, Open-End Ureteral Catheter Sof-Flex, EchoTip Open-End Ureteral Catheter, Open-End Flexi-Tip Ureteral Catheter, Flexi-Tip Ureteral Catheter (Closed End), Whistle Tip Ureteral Catheter, Round Tip Ureteral Catheter, Spiral Tip Ureteral Access Catheter, Pediatric Ureteral Catheter (K171662)Cook Incorporated2018-02-01
GentleCath Intermittent Urinary Catheter (K172924)Convatec Limited2017-11-21

Recalls involving this device

RecordFirmDate
Boston Scientific, IMAGER II Urology Torque Catheter, Sterilized with ethylene oxide gas. recall (Z-1393-2012)Boston Scientific Corporation2012-04-11

PMA approvals by this applicant

RecordFirmDate
Axonics Sacral Neuromodulation System (P180046/S113)Boston Scientific Corporation2026-08-07
Axonics Sacral Neuromodulation System (P190006/S113)Boston Scientific Corporation2026-08-07
Innova™ Self Expanding Stent System (P140028/S087)Boston Scientific Corporation2026-08-06
Ranger™ Paclitaxel-Coated Balloon Catheter (P190019/S043)Boston Scientific Corporation2026-08-04
AGENT™ Paclitaxel-Coated Balloon Catheter (P230035/S009)Boston Scientific Corporation2026-07-30
Axonics Sacral Neuromodulation System (P180046/S110)Boston Scientific Corporation2026-07-24
Axonics Sacral Neuromodulation System (P190006/S110)Boston Scientific Corporation2026-07-24
S-ICD EMBLEM™ GEN 2 (A209); S-ICD EMBLEM™ MRI (A219) (P110042/S215)Boston Scientific Corporation2026-07-23