Birtcher Medical Systems, Inc.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Birtcher Medical Systems, Inc.” (first 1991, latest 1995), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 279 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | 4 | 4 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 3 | 3 |
| HET | Laparoscope, Gynecologic (And Accessories) | 3 | 3 |
| GCI | Laryngoscope, Endoscope | 2 | 2 |
| GCY | Apparatus, Suction, Single Patient Use, Portable, Nonpowered | 1 | 1 |
Review panels
Most recent Birtcher Medical Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K932779 | BIRTCHER SWIVEL GRIP LAPAROSCOPIC PROBES & ACCESS. | HET | 1995-03-21 | 651 |
| K944681 | LECTROSURIGICAL, CUTTING AND COAGULATION AND ACCESSORIES | GEI | 1994-12-22 | 91 |
| K936114 | BIRTCHER PERICARDIAL KNIVES | GCJ | 1994-04-25 | 439 |
| K932987 | BIRTCHER LAPAROSCOPE AND ACCESSORIES | GCJ | 1994-04-25 | 311 |
| K931771 | BIRTCHER ENDOSCOPIC CORKSCREW | HET | 1994-04-25 | 381 |
| K931654 | BIRTCHER MAGNETIC RETRIEVER (GS-3100) | HET | 1994-04-25 | 385 |
| K930887 | BIRTCHER BRONCHUS & LUNG CLAMP (GS-1620 & GS-1600) | GCJ | 1994-04-25 | 430 |
| K933319 | BIRTCHER GS-9480 INTEGRATED 3-CHIP CAMERA/XENON LIGHT SOURCE VISUALIZATION SYSTEM | GCY | 1993-10-27 | 112 |
| K930302 | BIRTCHER SURE CLEAN INSTRUMENT SYSTEM | GCI | 1993-10-27 | 279 |
| K930496 | GI-1090,1095,1080,1085,1086,1088, ENDO. CLAMPS | GCI | 1993-04-20 | 78 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Birtcher Medical Systems, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Birtcher Corp. (27 510(k)s)
- Birtcher Electro Medical Systems (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Birtcher Medical Systems, Inc.?
FDA lists 13 510(k) clearances under the applicant name “Birtcher Medical Systems, Inc.” (first 1991, latest 1995), across 5 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Birtcher Medical Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Birtcher Medical Systems, Inc. is 279 days.
Which FDA product codes appear under Birtcher Medical Systems, Inc.?
The most frequent FDA product codes under this applicant name are GCJ (Laparoscope, General & Plastic Surgery, 4); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 3); HET (Laparoscope, Gynecologic (And Accessories), 3).
Next steps
- See all 13 Birtcher Medical Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GCJ, Birtcher Medical Systems, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.