Data / Medical devices / Vietnam / Olympus Vietnam Co. Ltd.
Olympus Vietnam Co. Ltd.: FDA-registered device maker in Dong Nai City, Vietnam, 20 510(k) clearances
Olympus Vietnam Co. Ltd. is registered with the FDA (registration 3008040402) in Dong Nai City, Vietnam. It lists 17 device types. The FDA files 20 510(k) clearances under its listings, the newest dated March 20, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3008040402
- Address
- 8 Street, Long Thanh Industrial Zone An Phuoc Commune, Dong Nai City, Vietnam, 810000
- Owner or operator
- OLYMPUS CORPORATION (9067818)
- Roles
- Manufacturer
- First device listed
- February 20, 2002
- Registered through
- 2027
- Brand names listed
- B-V233P-A, B-V233P-B, B-V243Q-A, B-V243Q-B, B-V433P-A, B-V433P-B, B-V443Q-A, B-V443Q-B and more
Devices it lists
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 |
|---|---|---|---|---|---|---|
| March 20, 2026 | K252050 | Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D | EOB | Substantially Equivalent | Olympus Medical Systems Corporation | accessdata.fda.gov |
| October 17, 2025 | K250945 | Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series) | KNS | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| October 16, 2025 | K252247 | Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use Injector (NM-400U); Injector Force Max Single Use Injector (NM-400Y); Injector Force Max Single Use Injector (NM-401L) | FBK | Substantially Equivalent | Olympus Medical Systems Corporation | accessdata.fda.gov |
| October 7, 2025 | K250187 | Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U) | KGE | Substantially Equivalent | Olympus Medical Systems Corporation | accessdata.fda.gov |
| July 29, 2025 | K251664 | Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022) | KTI | Substantially Equivalent | Olympus Medical Systems Corporation | accessdata.fda.gov |
| May 30, 2025 | K250957 | Disposable Biopsy Forceps (FB-211D); Disposable Biopsy Forceps (FB-221D); Disposable Biopsy Forceps (FB-231D); Disposable Biopsy Forceps (FB-241D) | EOQ | Substantially Equivalent | Olympus Medical Systems Corporation | accessdata.fda.gov |
| December 7, 2017 | K172734 | Single Use Electrosurgical Snare SD-400 | FDI | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| March 2, 2016 | K160241 | Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215 | KNS | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| February 12, 2016 | K153625 | Single Use Injector NM600/610 | FBK | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| March 31, 2015 | K141991 | SINGLE USE PRELOADED SPHINCTEROTOME V (DISTAL WIREGUIDED); SINGLE USE SP | KNS | Substantially Equivalent | Olympus Medical Systems Copr. | accessdata.fda.gov |
| April 11, 2013 | K122505 | SINGLE USE PRELOADED SPHINCTEROTOME V | KNS | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| September 3, 2009 | K091495 | SINGLE USE 3-LUMEN EXTRACTION BALLOON V, MODEL V B-V233P-A,B-V233P-B,B-V433P-A,B-V433P-B, BV243Q-A, B-V243Q-B, B-V443Q-A | LQR | Substantially Equivalent | Olympus Medical Systems Corporation | accessdata.fda.gov |
| May 12, 2005 | K050503 | SINGLE USE ASPIRATION NEEDLE NA-201SX-4022 | FCG | Substantially Equivalent | Olympus Medical Systems Corporation | accessdata.fda.gov |
| December 11, 2001 | K013066 | HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE | MND | Substantially Equivalent | Olympus America, Inc. | accessdata.fda.gov |
| March 29, 1996 | K955650 | OLYMPUS SD SERIES SNARES | FDI | Substantially Equivalent | Olympus America, Inc. | accessdata.fda.gov |
| May 3, 1995 | K951445 | OLYMPUS FD-5 HOT BIOPSY FORCEPS | KGE | Substantially Equivalent | Olympus America, Inc. | accessdata.fda.gov |
| February 27, 1995 | K950636 | OLYMPUS DISPOSABLE BIOPSY FORCEPS | EOQ | Substantially Equivalent | Olympus America, Inc. | accessdata.fda.gov |
| February 22, 1995 | K950166 | OLYMPUS KD-6G1-9Q WIRE GUIDED PAPILLOTOMU KNIFE | KNS | Substantially Equivalent | Olympus America, Inc. | accessdata.fda.gov |
| August 24, 1990 | K902736 | NM INJECTION NEEDLES | FBK | Substantially Equivalent | Olympus Corp. | accessdata.fda.gov |
| August 2, 1990 | K902735 | SD SNARES | GEI | Substantially Equivalent | Olympus Corp. | accessdata.fda.gov |
Compare with other makers
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- All makers of Forceps, Biopsy, Non-Electric
- All makers of Snare, Flexible
Updated March 20, 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.