Birtcher Medical Systems, Inc.
San Jose, CA, US
Birtcher Medical Systems, Inc. appears in FDA device records in San Jose, CA. FDA records list 13 510(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
- 13
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 13 510(k) clearances for Birtcher Medical Systems, Inc. between 1991 and 1995. The busiest year on record is 1994, with 6. The most recent is 1995, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1991 | 1 |
| 1992 | 1 |
| 1993 | 4 |
| 1994 | 6 |
| 1995 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K932779 | BIRTCHER SWIVEL GRIP LAPAROSCOPIC PROBES & ACCESS. | HET | Substantially Equivalent | |
| K944681 | LECTROSURIGICAL, CUTTING AND COAGULATION AND ACCESSORIES | GEI | Substantially Equivalent | |
| K936114 | BIRTCHER PERICARDIAL KNIVES | GCJ | Substantially Equivalent | |
| K932987 | BIRTCHER LAPAROSCOPE AND ACCESSORIES | GCJ | Substantially Equivalent | |
| K931771 | BIRTCHER ENDOSCOPIC CORKSCREW | HET | Substantially Equivalent | |
| K931654 | BIRTCHER MAGNETIC RETRIEVER (GS-3100) | HET | Substantially Equivalent | |
| K930887 | BIRTCHER BRONCHUS & LUNG CLAMP (GS-1620 & GS-1600) | GCJ | Substantially Equivalent | |
| K933319 | BIRTCHER GS-9480 INTEGRATED 3-CHIP CAMERA/XENON LIGHT SOURCE VISUALIZATION SYSTEM | GCY | Substantially Equivalent | |
| K930302 | BIRTCHER SURE CLEAN INSTRUMENT SYSTEM | GCI | Substantially Equivalent | |
| K930496 | GI-1090,1095,1080,1085,1086,1088, ENDO. CLAMPS | GCI | Substantially Equivalent | |
| K925824 | SOLOS FAN RETRACTORS | GCJ | Substantially Equivalent | |
| K925903 | LAPAROSCOPIC 5MM ABC PROBE, MODIFICATION | GEI | Substantially Equivalent | |
| K910889 | ABC LAPAROSCOPIC HANDPROBE | GEI | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
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