Origin Medsystems, Inc.: FDA filings under this applicant name
FDA lists 50 510(k) clearances under the applicant name “Origin Medsystems, Inc.” (first 1989, latest 1999), across 12 product codes in 5 review panels. Median 510(k) review time under this name: 100 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 | 34 | 34 |
| HET | Laparoscope, Gynecologic (And Accessories) | 4 | 4 |
| FHO | Pneumoperitoneum Needle | 2 | 2 |
| LZV | System, Cement Removal Extraction | 2 | 2 |
| DXC | Clamp, Vascular | 1 | 1 |
| GEA | Cannula, Surgical, General & Plastic Surgery | 1 | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| GEX | Powered Laser Surgical Instrument | 1 | 1 |
| HRX | Arthroscope | 1 | 1 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 1 | 1 |
Plus 2 more product codes.
Review panels
- General and Plastic Surgery (37)
- Gastroenterology and Urology (4)
- Obstetrics and Gynecology (4)
- Orthopedic (4)
- Cardiovascular (1)
Most recent Origin Medsystems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K992353 | BLUNT TIP TROCAR PORT | GCJ | 1999-07-30 | 16 |
| K981700 | VASOVIEW DISSECTION/VESSEL HARVESTING SYSTEM | GCJ | 1998-05-29 | 15 |
| K972685 | ORIGIN LIGATOR DEVICE | GCJ | 1997-10-01 | 76 |
| K970611 | ORIGIN CARDIAC STABLIZER OCCLUDER | DXC | 1997-08-19 | 182 |
| K965121 | CANNULA | HET | 1997-03-20 | 87 |
| K964171 | VASOVIEW BALLOON DISSECTION SYSTEM | GCJ | 1997-02-14 | 119 |
| K962104 | AIRLIFT BALLOON RETRACTON SYSTEM | GCJ | 1996-09-11 | 104 |
| K962005 | EXTRAHAND BALLOON RETRACTOR | GCJ | 1996-08-12 | 82 |
| K960936 | RESPOSABLE TROCAR SYSTEM [5MM, 5MM SHORT, 10MM AND 12MM SIZES] | HET | 1996-07-24 | 138 |
| K960637 | 5MM ENDOSCOPE | GCJ | 1996-06-14 | 121 |
40 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Origin Medsystems, 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.
- Origin Medical Devices (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Origin Medsystems, Inc.?
FDA lists 50 510(k) clearances under the applicant name “Origin Medsystems, Inc.” (first 1989, latest 1999), across 12 product codes in 5 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 Origin Medsystems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Origin Medsystems, Inc. is 100 days.
Which FDA product codes appear under Origin Medsystems, Inc.?
The most frequent FDA product codes under this applicant name are GCJ (Laparoscope, General & Plastic Surgery, 34); HET (Laparoscope, Gynecologic (And Accessories), 4); FHO (Pneumoperitoneum Needle, 2).
Next steps
- See all 50 Origin Medsystems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GCJ, Origin Medsystems, 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.