Sidecar External Working Channel

FDA 510(k) clearance K150083 · decided 2015-04-14

Clearance details

K-number: K150083
Device name: Sidecar External Working Channel
Applicant: C2 Therapeutics
Decision: Substantially Equivalent
Date received: 2015-01-15
Decision date: 2015-04-14
Days to decision: 89 days
Clearance type: Traditional
Product code: FED
Device class: 2
Regulation number: 876.1500
Medical specialty: Gastroenterology, Urology
Advisory committee: Gastroenterology, Urology
Location: Redwood, Ca, CA, US
Third-party review: No
Expedited review: No

+ Add to Predicate Builder ◉ Watch C2 Therapeutics

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.

Record	Firm	Date
CVAC Aspiration System (K260965)	Calyxo, Inc.	2026-04-13
ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250) (K260521)	Zhuhai Pusen Medical Technology Co., Ltd.	2026-04-06
Prodeon Urethral Sheath System (K252572)	Prodeon Medical, Inc.	2025-10-07
Single Use Suction-Evacuation Ureteral Access Sheath (K250128)	Anhui Happiness Workshop Medical Instruments Co., Ltd.	2025-09-19
Ureteral Access Sheath (K250132)	Zhejiang YiGao Medical Technology Co., Ltd.	2025-09-05
Single-use Ureteral Access Sheath (K250695)	Shenzhen HugeMed Medical Technical Development Co., Ltd.	2025-07-08
Single-use Ureteral Access Sheath (K251599)	Hunan Vathin Medical Instrument Co., Ltd.	2025-07-03
LumenaTM Ureteral Access Sheath (K250585)	Cathegenix (Xiamen) Co., Ltd.	2025-06-27
CoralWell™ Single-use Ureteral Access Sheath (NS-0835B, NS-0840B, NS-0845B, NS-0855B, NS-0935B, NS-0940B, NS-0945B, NS-0955B, NS-1035B, NS-1040B, NS-1045B, NS-1055B, NS-1135B, NS-1140B, NS-1145B, NS-1155B, NS-1235B, NS-1240B, NS-1245B, NS-1255B, NS-1335B, NS-1340B, NS-1345B, NS-1355B, NS-1435B, NS-1440B, NS-1445B, NS-1455B) (K250452)	MacroLux Medical Technology Co., Ltd.	2025-06-02
Disposable ureteral access sheath (K243710)	Shenzhen Trious Medical Technology Co., Ltd.	2025-04-11
Navigator™ HD Ureteral Access Sheath Set 11/13 F x 28cm (M0062502210); Navigator™ HD Ureteral Access Sheath Set 11/13 F x 36cm (M0062502220); Navigator™ HD Ureteral Access Sheath Set 11/13 F x 46cm (M0062502230); Navigator™ HD Ureteral Access Sheath Set 12/14 F x 28cm (M0062502240); Navigator™ HD Ureteral Access Sheath Set 12/14 F x 36cm (M0062502250); Navigator™ HD Ureteral Access Sheath Set 12/14 F x 46cm (M0062502260); Navigator™ HD Ureteral Access Sheath Set 13/15 F x 28cm (M006 (K250517)	Boston Scientific Corporation	2025-03-21
Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040, IVX-NS-1050, IVX-NS-1140, IVX-NS-1150, IVX-NS-1240, IVX-NS-1250 (K243820)	Dornier Medtech America	2025-01-31

Recalls involving this device

No recalls on record reference this clearance.