Exelint International Co.
Redondo Beach, CA, US
EXELINT INTERNATIONAL, CO. appears in FDA device records in Redondo Beach, CA. FDA records list 7 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 7 510(k) clearances for Exelint International Co. between 2000 and 2025. The busiest year on record is 2001, with 2. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2000 | 1 |
| 2001 | 2 |
| 2003 | 1 |
| 2010 | 1 |
| 2015 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K251089 | EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Syringe with Secure Touch® Safety Needle; EXEL Disposable Hypodermic Needle | FMF | Substantially Equivalent | |
| K152183 | EXELINT SecureTouch Safety Hypodermic Needle | FMI | Substantially Equivalent | |
| K101309 | EXELINT ALUMINUM HUB BLUNT NEEDLES | LHI | Substantially Equivalent | |
| K020189 | EXEL BUTTERFLY SCALP VEIN SET | FPA | Substantially Equivalent | |
| K010197 | EXEL SECURE TOUCH SAFETY (P.S.V.) SCALP VEIN SET | FPA | Substantially Equivalent | |
| K003627 | EXEL SECURE TOUCH SAFETY A.V. FISTULA NEEDLE SET | FMI | Substantially Equivalent | |
| K001496 | A.V. FISTULA NEEDLE | FIE | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1035907 | 1035907 | EXELINT INTERNATIONAL, CO. | 2500 Santa Fe Avenue, Redondo Beach, CA 90278 US | 2026 | and 4 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- IQGAdaptor, Holder, Syringe
- GESBlade, Scalpel
- FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- FMHContainer, Specimen, Sterile
- DZMNeedle, Dental
- FIENeedle, Fistula
- FMINeedle, Hypodermic, Single Lumen
- GDXScalpel, One-Piece
- FPASet, Administration, Intravascular
- LHISet, I.V. Fluid Transfer
- MEGSyringe, Antistick
- KYZSyringe, Irrigating (Non Dental)
- FMFSyringe, Piston
- EIDSyringe, Restorative And Impression Material
- KGXTape And Bandage, Adhesive
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0640-2010 | Exel Huber Infusion Set (Catalog Numbers 26940R, 26941R, 26944R, 26945R, 26946R, 26948R, 26949R, 26950R, 27940R, 27941R, 27944R, 27945R, 27946R, 27948R, 27949R, 27950R, 26954R, 26955R, 26958R, 26959R, 27954R, 27955R, 27958R, 27959R). | Coring of port's septum, which may lead to: Decreased effectiveness of port, infection, necrosis, swelling, and embolization, which may result in Pulmonary Embolism, Limb ischemia, stroke, local extravasation of medication such as chemotherapy or other caustic material, may lead to local tissue necrosis, granulomas, failure to deliver therapy, need for additional surgery to replace implanted port | Terminated | ||
| Z-0639-2010 | Exel Safety Huber Infusion Sets (20G and 22G sizes with Catalog Numbers 37854S, 37855S. 37858S). | Coring of port's septum, which may lead to: Decreased effectiveness of port, infection, necrosis, swelling, and embolization, which may result in Pulmonary Embolism, Limb ischemia, stroke, local extravasation of medication such as chemotherapy or other caustic material, may lead to local tissue necrosis, granulomas, failure to deliver therapy, need for additional surgery to replace implanted port | Terminated | ||
| Z-0638-2010 | Exel Huber Needles (Right angle and Straight Models with Catalog Numbers: 26901CE, 26902CE, 26903CE, 26904CE, 26905CE, 26906CE, 26907CE, 26908CE, 26909CE, 26910CE, 26911CE, 26921CE, 26922CE, 26923CE, 26924CE, 26925CE, 26926CE, 26927CE, 26928CE, and 26929CE). | Non-coring needles that, when inserted into an implanted port, were shown to core the silicone port's septum. Coring of port's septum may lead to: decreased effectiveness of port, infection, necrosis, swelling, and embolization, which may result in pulmonary embolism, limb ischemia, stroke, local extravasation of medication such as chemotherapy or other caustic material; may lead to local tissue | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain