Accurate Surgical Instruments Co.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Accurate Surgical Instruments Co.” (first 1981, latest 1995), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 171 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 |
|---|---|---|---|
| FJS | Catheter, Peritoneal, Long-Term Indwelling | 7 | 7 |
| FKO | Catheter, Peritoneal Dialysis, Single Use | 1 | 1 |
| FKX | System, Peritoneal, Automatic Delivery | 1 | 1 |
Review panels
Most recent Accurate Surgical Instruments Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K950042 | SWAN NECK PRESTERNAL PERITONEAL DIALYSIS CATHETER | FJS | 1995-12-15 | 344 |
| K920515 | INSERTION | FJS | 1992-05-04 | 90 |
| K910786 | TROCAR (FALLER STYLET) | FJS | 1991-09-19 | 206 |
| K910785 | TITANIUM CATHETER EXTENDER | FJS | 1991-08-22 | 178 |
| K910787 | TITANIUM CONNECTOR (2 PART) | FKO | 1991-08-15 | 171 |
| K862046 | SWAN-NECK PERITONEAL DIALYSIS CATHETERS | FJS | 1986-06-19 | 21 |
| K850214 | STERILE CATHETERS-CATHETER PERITONEAL LONG-TERM IN | FJS | 1985-07-26 | 185 |
| K813488 | CATHETER REGULAR | FJS | 1981-12-31 | 30 |
| K813487 | CATHETER BUBBLE STAND | FKX | 1981-12-31 | 30 |
Recalls
openFDA lists no recalls under a recalling firm named Accurate Surgical Instruments Co..
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.
- Accurate Medical Therapeutics, Ltd. (4 510(k)s)
- Accurate Meditech, Inc. (2 510(k)s)
- Accurate Access, LLC (1 510(k)s)
- Accurate Medical Devices, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Accurate Surgical Instruments Co.?
FDA lists 9 510(k) clearances under the applicant name “Accurate Surgical Instruments Co.” (first 1981, latest 1995), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Accurate Surgical Instruments Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Accurate Surgical Instruments Co. is 171 days.
Which FDA product codes appear under Accurate Surgical Instruments Co.?
The most frequent FDA product codes under this applicant name are FJS (Catheter, Peritoneal, Long-Term Indwelling, 7); FKO (Catheter, Peritoneal Dialysis, Single Use, 1); FKX (System, Peritoneal, Automatic Delivery, 1).
Next steps
- See all 9 Accurate Surgical Instruments Co. clearances with predicates and recalls
- Run predicate analysis for product code FJS, Accurate Surgical Instruments Co.'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.