Data / Medical devices / United States / OBP Medical Corporation
OBP Medical Corporation: FDA-registered device maker in Lawrence, MA, United States, 3 510(k) clearances
OBP Medical Corporation is registered with the FDA (registration 3007789561) in Lawrence, MA, United States. It lists 9 device types. The FDA files 3 510(k) clearances under its listings, the newest dated July 27, 2012. 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
- 3007789561
- Address
- 360 MERRIMACK STREET Building 9, Lawrence, MA, United States, 01843
- Owner or operator
- OBP Medical Corporation (10025921)
- Roles
- Specification developer
- First device listed
- May 21, 2008
- Registered through
- 2026
- Brand names listed
- C020001 - OfficeSPEC Medium, Non-Sterile, C020100-1 - ER SPEC Small, Non-Sterile, C020110-1 - ER SPEC Medium, Non-Sterile, C020120-1 - ER SPEC Large, Non-Sterile, C020130-1 - ER SPEC XSMALL, Non-Sterile, C020140-1 - ER SPEC XLARGE, Non-Sterile, C020300 - ER-Spec Small, Sterile, C020310 - ER-Spec Medium, Sterile and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Anoscope And Accessories | FER | 2 | Specification developer | accessdata.fda.gov |
| Catheter And Tip, Suction | JOL | 2 | Specification developer | accessdata.fda.gov |
| Endoscope Channel Accessory | ODC | 2 | Specification developer | accessdata.fda.gov |
| Hysteroscope (And Accessories) | HIH | 2 | Specification developer | accessdata.fda.gov |
| Hysteroscope Accessories | NWW | 1 | Specification developer | accessdata.fda.gov |
| Laparoscope, Gynecologic (And Accessories) | HET | 2 | Specification developer | accessdata.fda.gov |
| Laryngoscope, Rigid | CCW | 1 | Specification developer | accessdata.fda.gov |
| Retractor | GAD | 1 | Specification developer | accessdata.fda.gov |
| Speculum, Vaginal, Nonmetal | HIB | 2 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| July 27, 2012 | K121604 | ANOSPEC DISPOSABLE ANSOSCOPE WITH LIGHT | FER | Substantially Equivalent | Obp Corporation | accessdata.fda.gov |
| December 4, 2009 | K091838 | OBP SELF SEALING ENDOSCOPIC SEAL WITH LUER LOCK | HIH | Substantially Equivalent | Obp Medical | accessdata.fda.gov |
| September 9, 2009 | K091937 | OFFICE-SPEC DISPOSABLE SIDE-OPENING SPECULUM | HIB | Substantially Equivalent | Obp Corporation | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 13, 2026 | 99433 | Class II | Ongoing | OBP Medical, ER-Spec Single-Use Vaginal Speculum with LED Light Source, X-Small REF: C020130-1 | There is a potential for vaginal speculums to contain a burr on the proximal plastic blade, which may introduce a sharp edge in the contact regions for both the patient and the healthcare provider. | accessdata.fda.gov |
Compare with other makers
- All makers of Laparoscope, Gynecologic (And Accessories)
- All makers of Endoscope Channel Accessory
- All makers of Hysteroscope (And Accessories)
- All makers of Speculum, Vaginal, Nonmetal
- All makers of Retractor
- All makers of Anoscope And Accessories
Updated August 10, 2026. 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.