Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007789561

FEI Number

3007789561

Entity Name

OBP Medical Corporation

City/State/Country

Lawrence, MA, US

Establishment Address

360 MERRIMACK STREET, Building 9, Lawrence, MA 01843, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

OBP Medical Corporation (Owner Number: 10025921)

Owner / Operator Contact Address

95 Corporate Drive, Trumbull, CT 06611, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

OfficeSPEC ER-SPEC/OfficeSPEC ER-SPEC HER-SPEC SURE-SCOPE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2020-07-27
HIB	Speculum, Vaginal, Nonmetal	Obstetrics/Gynecology	Class 2	884.4530	2010-03-23
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2010-03-23
ODC	Endoscope Channel Accessory	Gastroenterology, Urology	Class 2	876.1500	2010-03-23
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2010-03-23
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2014-04-24
NWW	Hysteroscope Accessories	Obstetrics/Gynecology	Class 1	884.1690	2008-05-21

Official Correspondent

Brian Szeremeta

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

OBP Medical Corporation

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K936071	Smith & Nephew Dyonics, Inc.	SMITH & NEPHEW DYONICS INC. ELECTRONIC ENDOSCOPE	1994-08-19
K953574	American Hydro-Surgical Instruments, Inc.	NEZHAT-DORSEY HYDRO-DISSECTION UNIVERSAL BAG SQUEEZER	1995-09-29
K935716	KARL STORZ Endoscopy-America, Inc.	KARL STORZ FIXED MAGNIFICATION TELESCOPE/KS VARIABLE MAGNIFICATION TELESCOPE	1995-11-16

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2013	Invuity, Inc.	2	BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray. The Invuity Brite Field Illuminated Suction Device is intended to aspirate from the surgical site and to provide illumination from a high intensity light source.
Z-0023-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Separator Abdominal Access System REF: C0604 15 x 100mm Non-threaded Separator System with Universal Seal, for laparoscopic procedures.
Z-0024-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Separator Abdominal Access System REF:C0605 15x100mm Threaded Separator System with Universal Seal, for laparoscopic procedures.
Z-0025-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Separator Abdominal Access System REF: C0606 15x150mm Non-threaded Separator System with Universal Seal, for laparoscopic procedures.
Z-0026-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Separator Abdominal Access System REF: C0607 15x150mm Threaded Separator System with Universal Seal, for laparoscopic procedures.

Similar Registrations

Registration Number	Establishment Name	Location
3007477849	PATIENT SHIELD CONCEPTS LLC	Denver, CO, US
3019385708	OBP SURGICAL CORPORATION	Lawrence, MA, US
3025831202	TKR HUANAN ELECTRONICS (DONGGUAN) CO., LTD.	Dongguan City Guangdong, CN
3027150141	SWIFTSURE INNOVATIONS INC.	Pasadena Newfoundland and Labrador, CA
3015337348	Primecare Medical (Suzhou) Co.,Ltd.	Changshu Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007789561. Last updated year: 2026. Please use registration number 3007789561 when referencing this establishment in official correspondence.