Data / Medical devices / United States / Hobbs Medical, Inc.

Hobbs Medical, Inc.: FDA-registered device maker in Stafford Springs, CT, United States, 13 510(k) clearances

Name: Hobbs Medical, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Hobbs Medical, Inc. is registered with the FDA (registration 1220592) in Stafford Springs, CT, United States. It lists 13 device types. The FDA files 13 510(k) clearances under its listings, the newest dated September 24, 2024. 6 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this one Watch Hobbs Medical, Inc.

FDA registration number: 1220592
Address: 8 Spring St, Stafford Springs, CT, United States, 06076
Owner or operator: Hobbs Medical Inc (1220592)
Roles: Contract manufacturer, Contract sterilizer, Manufacturer, Repackager or relabeler
First device listed: September 14, 1984
Registered through: 2026
Brand names listed: Aspiration Catheter, Biliary Pigtail Stent, CleanCapture Aspiration Catheter, Freeman Pancreatic Flexi-Stent - Single Pigtail, Freeman Pancreatic Flexi-Stent - Straight, Gastrointestinal Cytology Brush, Guide Catheter, Hobbs Medical Good-Bi Brush and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Cleaning, For Endoscope	FEB	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Bronchoscope (Flexible Or Rigid)	EOQ	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Brush, Biopsy, Bronchoscope (Non-Rigid)	BTG	2	Contract manufacturer, Contract sterilizer, Manufacturer, Repackager or relabeler	accessdata.fda.gov
Brush, Biopsy, General & Plastic Surgery	GEE	1	Manufacturer	accessdata.fda.gov
Cannula, Injection	FGY	1	Manufacturer	accessdata.fda.gov
Endoscopic Cytology Brush	FDX	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Endoscopic Grasping/Cutting Instrument, Non-Powered	OCZ	2	Manufacturer	accessdata.fda.gov
Endoscopic Injection Needle, Gastroenterology-Urology	FBK	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Endoscopic Irrigation/Suction System	OCX	2	Manufacturer	accessdata.fda.gov
Fixative, Alcohol Containing	LDZ	1	Repackager or relabeler	accessdata.fda.gov
Needle, Aspiration And Injection, Disposable	GAA	1	Manufacturer	accessdata.fda.gov
Stents, Drains And Dilators For The Biliary Ducts	FGE	2	Manufacturer	accessdata.fda.gov
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	KNS	2	Contract manufacturer, 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
September 24, 2024	K241874	Aspiration Catheter (2189)	OCX	Substantially Equivalent	Hobbs Medical, Inc.	accessdata.fda.gov
February 7, 2020	K182927	Pulmonary Cytology Brush	BTG	Substantially Equivalent	Hobbs Medical, Inc.	accessdata.fda.gov
August 2, 2010	K093079	TOUCHSOFT COAGULATOR WITH BANANA FITTING, MODEL 4581 AND WITH UNIVERSAL FITTING, MODEL 4581-U	KNS	Substantially Equivalent	Hobbs Medical, Inc.	accessdata.fda.gov
June 9, 2003	K030765	HOBBS MISTIFIER SPRAY CATHETER	OCX	Substantially Equivalent	Hobbs Medical, Inc.	accessdata.fda.gov
October 28, 1993	K933354	HOBBS MEDICAL CLEANING BRUSH	FEB	Substantially Equivalent	Hobbs Medical, Inc.	accessdata.fda.gov
August 28, 1989	K893729	HOBBS MEDICAL MICROBIOLOGY BRUSH	FDX	Substantially Equivalent	Hobbs Medical, Inc.	accessdata.fda.gov
March 4, 1986	K860582	TBI NEEDLE	GAA	Substantially Equivalent	Hobbs Medical, Inc.	accessdata.fda.gov
January 3, 1985	K844550	HOBBS MEDICAL/JAYCO ASPIRATION CATHETER	OCX	Substantially Equivalent	Hobbs Medical, Inc.	accessdata.fda.gov
January 3, 1985	K844074	HOBBS MEDICAL POLYPECTOMY SNARE	OCZ	Substantially Equivalent	Hobbs Medical, Inc.	accessdata.fda.gov
March 22, 1984	K834351	BILIARY INDWELLING STENT	FGE	Substantially Equivalent	Hobbs Medical, Inc.	accessdata.fda.gov
February 4, 1984	K834403	INJECTION NEEDLE	FBK	Substantially Equivalent	Bobbs Medical, Inc.	accessdata.fda.gov
February 4, 1984	K834402	GASTROINTESTINAL SHEATH BRUSH	FDX	Substantially Equivalent	Hobbs Medical, Inc.	accessdata.fda.gov
October 31, 1983	K833125	HOBBS MEDICAL GRASPING FORCEPS	OCZ	Substantially Equivalent	Hobbs Medical, 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
October 4, 2024	95577	Class II	Ongoing	Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4720	Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle.	accessdata.fda.gov
July 29, 2022	90769	Class II	Ongoing	Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 260cm Disposable For endoscopy procedures Ref: 2190	Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)	accessdata.fda.gov
June 3, 2022	90456	Class II	Ongoing	Hobbs Medical Polypectomy Snare, Catalog No. 7202	During use, the sheath of the device may accordion at the proximal end where the sheath meets the shrink band. Kinking of the sheath may prevent the snare from fully closing, and injury may result.	accessdata.fda.gov
December 28, 2021	89488	Class II	Ongoing	Bronchial Microbiology Brush, Catalog Number 4310 and 4320. Microbial sampling is performed by compressing a spring as the base of brush wire to expose the brush, scraping the desired surface, and releasing the compressi	The labeling for the Microbiology Brush identifies the device as a Bronchial Microbiology Brush. The device is only cleared for gastrointestinal use and is not cleared for bronchial use.	accessdata.fda.gov
May 1, 2018	79903	Class II	Terminated	Hobbs Bronchial Cytology Brushes, Model Number 4202; 4204; 4206 To be utilized by a trained physician and/or trained personnel through a flexible endoscope when brush cell samples are required for cytological analysis.	Device was marketed for uses outside the 510(k) clearance.	accessdata.fda.gov
March 15, 2006	35011	Not yet classified	Terminated	Hobbs Medical 3 Prong Looped Retriever, a disposable device to be used by physician to remove foreign object or cauterize polyp specimens from the GI tract. REF: 5030 and 5030S	Diameter of device at the distal end would prevent it from passing through the endoscope's working channel.	accessdata.fda.gov

Compare with other makers

Updated November 15, 2024. 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.