Data / Medical devices / United States / Boston Scientific Corporation

Boston Scientific Corporation: FDA-registered device maker in Johns Creek, GA, United States, 6 510(k) clearances

Name: Boston Scientific Corporation FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Boston Scientific Corporation is registered with the FDA (registration 3032507796) in Johns Creek, GA, United States. It lists 13 device types. The FDA files 6 510(k) clearances under its listings, the newest dated October 9, 2025. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3032507796
Address: 11480 Lakefield Drive, Johns Creek, GA, United States, 30097
Owner or operator: Boston Scientific Corporation (9912058)
Roles: Manufacturer, Repackager or relabeler
First device listed: October 11, 2001
Registered through: 2026

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Cleaning Brushes, For Endoscope	MNL	1	Manufacturer	accessdata.fda.gov
Bedding, Disposable, Medical	KME	1	Manufacturer	accessdata.fda.gov
Bottle, Collection, Vacuum	KDQ	2	Manufacturer	accessdata.fda.gov
Cardiovascular Procedure Kit	OEZ	2	Manufacturer	accessdata.fda.gov
Endoscope Channel Accessory	ODC	2	Manufacturer	accessdata.fda.gov
Endoscopic Bite Block	MNK	1	Manufacturer	accessdata.fda.gov
Endoscopic Irrigation/Suction System	OCX	2	Manufacturer	accessdata.fda.gov
Gauze / Sponge,Nonresorbable For External Use	NAB	1	Repackager or relabeler	accessdata.fda.gov
Gown, Surgical	FYA	2	Manufacturer	accessdata.fda.gov
Lubricant, Patient	KMJ	1	Repackager or relabeler	accessdata.fda.gov
Pump, Air, Non-Manual, For Endoscope	FEQ	2	Manufacturer	accessdata.fda.gov
Syringe, Irrigating (Non Dental)	KYZ	1	Repackager or relabeler	accessdata.fda.gov
Tubing, Noninvasive	GAZ	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
October 9, 2025	K252910	Orca Air/Water and Suction Valves	ODC	Unknown	Boston Scientific	accessdata.fda.gov
February 21, 2022	K203548	EndoArmor + Surgical Gown	FYA	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
September 13, 2018	K182275	Seal Single Use Biopsy Valve	OCX	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
June 27, 2016	K161482	EndoChoice Water Bottle Cap Irrigation System	FEQ	Substantially Equivalent	Endochoice, Inc.	accessdata.fda.gov
May 19, 2016	K160403	SmartStart Air/Water and Suction Valves	ODC	Substantially Equivalent	Endochoice, Inc.	accessdata.fda.gov
February 24, 2016	K153588	EndoChoice Water Bottle Cap System	FEQ	Substantially Equivalent	Endochoice, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
December 18, 2015	73067	Class II	Terminated	Fuse 1C Colonoscope	The bending section of the device may partially separate from the insertion tube. Potential for tissue trauma.	accessdata.fda.gov

Compare with other makers

Updated October 9, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.