Byron Medical
Tucson, AZ, US
Byron Medical appears in FDA device records in Tucson, AZ. FDA records list 27 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 27
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 27 510(k) clearances for Byron Medical between 1986 and 2004. The busiest year on record is 1986, with 8. The most recent is 2004, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1986 | 8 |
| 1988 | 1 |
| 1989 | 1 |
| 1991 | 5 |
| 1992 | 1 |
| 1994 | 3 |
| 1997 | 1 |
| 1998 | 5 |
| 2000 | 1 |
| 2004 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K040149 | PSI-TEC PERISTALTIC INFILTRATION PUMP | FRN | Substantially Equivalent | |
| K001803 | ACCELERATOR RECIPROCATING CANNULA | QPB | Substantially Equivalent | |
| K981215 | PSI-TEC LIPOSUCTION ASPIRATOR | QPB | Substantially Equivalent | |
| K981172 | LIPOPLASTY/ LIPOSUCTION ASPIRATION AND TUMESCENT INFUSION CANNULAE AND NEEDLES | QPB | Substantially Equivalent | |
| K980738 | PSI-TEC SYRINGE INFUSION PUMP AND ACCESSORIES FOR GENERAL FLUID IRRIGAION/INFILTRATION | FRN | Substantially Equivalent | |
| K980392 | PSI-TEC ASPIRATOR | BTA | Substantially Equivalent | |
| K974295 | BYRON MEDICAL ASPIRATION AND INFILTRATION/IRRIGATION TUBING | KGZ | Substantially Equivalent | |
| K973133 | BIG BAG 3000 PRESSURE INFUSOR | FRN | Substantially Equivalent - Subject to Tracking Reg. | |
| K934179 | DISPOSABLE BAG DECANTER | KPE | Substantially Equivalent | |
| K934233 | ZARA ZONE IV MALAR IMPLANT MODIFICATION | LZK | Substantially Equivalent | |
| K933670 | BIOPSY PUNCH, SURGICAL | EME | Substantially Equivalent | |
| K913882 | ZARA SILICONE BLOCK | MIB | Substantially Equivalent | |
| K914016 | ZARA ZONE IV MALAR IMPLANT | LZK | Substantially Equivalent | |
| K910436 | ELASTIC ADHESIVE BANDAGE | KGX | Substantially Equivalent | |
| K910458 | ZARA SOFT TIP CHIN IMPLANT | FWP | Substantially Equivalent | |
| K910457 | ZARA EXTENDED CHIN IMPLANT | FWP | Substantially Equivalent | |
| K910456 | ZARA CHIN IMPLANT | FWP | Substantially Equivalent | |
| K895865 | SERENE WRAP | EFQ | Substantially Equivalent | |
| K881460 | SMOKEVAC ELECTORSURGICAL PENCIL | GEI | Substantially Equivalent | |
| K863397 | BYRON SILICONE CHIN IMPLANTS | FWP | Substantially Equivalent | |
| K863430 | BYRON BIVALVE NASAL SPLINTS | FZE | Substantially Equivalent | |
| K863400 | BYRON EXTENDED MALAR AND BYRON CONTOURED MALAR | LZK | Substantially Equivalent | |
| K863399 | BYRON DORSAL COLUMELLA IMPLANT | FZE | Substantially Equivalent | |
| K863398 | BYRON NASAL SEPTAL BUTTON | FZE | Substantially Equivalent | |
| K862936 | NEWMAN CANNULAE SYSTEM (NCS) | GEA | Substantially Equivalent for Some Indications | |
| K861878 | BYRON SUCTION TIPS | Substantially Equivalent for Some Indications | ||
| K861877 | BYRON WORD BARTHOLIAN GLAND CATHETER | GBA | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KGZAccessories, Catheter
- GEACannula, Surgical, General & Plastic Surgery
- GBACatheter, Balloon Type
- KPEContainer, I.V.
- MIBElastomer, Silicone Block
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- EFQGauze/Sponge, Internal
- LZKImplant, Malar
- FWPProsthesis, Chin, Internal
- FZEProsthesis, Nose, Internal
- FRNPump, Infusion
- BTAPump, Portable, Aspiration (Manual Or Powered)
- EMEPunch, Biopsy, Surgical
- QPBSystem, Suction, Lipoplasty For Removal
- KGXTape And Bandage, Adhesive
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain