Access Surgical Intl., Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Access Surgical Intl., Inc.” (first 1992, latest 1995), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 61 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 | 6 | 6 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | 2 |
| OCZ | Endoscopic Grasping/Cutting Instrument, Non-Powered | 1 | 1 |
Review panels
Most recent Access Surgical Intl., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K954536 | BLADE, SCALPEL & BLADE, HANDEL | OCZ | 1995-11-29 | 61 |
| K953376 | ACCESS POINT | GCJ | 1995-09-12 | 56 |
| K945545 | ACCESS SURGICAL INT'L THORACIC ENDOSCOPIC SURGICAL INSTRUMENTS | GCJ | 1995-01-12 | 59 |
| K944974 | ACCESS POINT | GCJ | 1994-11-08 | 28 |
| K940587 | FLEX-I-PORT | GCJ | 1994-03-29 | 49 |
| K933192 | ACCESS SURGICAL INT'L INC. ENDOSCOPIC SURG. INST. | GCJ | 1993-11-18 | 141 |
| K922424 | ACCESS SURGICAL INT'L ENDOSCOPIC SURGICAL INSTRUM. | GCJ | 1992-11-25 | 188 |
| K922423 | ACCESS SURGICAL BIPOLAR ENDOSCOPIC SURG. INSTRUM. | GEI | 1992-11-18 | 181 |
| K922425 | ACCESS SURGICAL MONOPOLAR ENDOSCOPIC SURG. INSTRUM | GEI | 1992-11-17 | 180 |
Recalls
openFDA lists no recalls under a recalling firm named Access Surgical Intl., 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.
- Access Scientific, Inc. (14 510(k)s)
- Access Vascular, Inc. (9 510(k)s)
- Access Bio Incorporate (4 510(k)s)
- Access / God Loves You (4 510(k)s)
- Access Point Medical, LLC (4 510(k)s)
- Access Bio, Inc. (3 510(k)s)
- Access Devices, Inc. (3 510(k)s)
- Access Battery, Inc. (2 510(k)s)
- Access Cardiosystems, Inc. (2 510(k)s)
- Access Pharmaceuticals, Inc. (2 510(k)s)
- Access Radiology Corp. (2 510(k)s)
- Access Point Technologies Ep, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Access Surgical Intl., Inc.?
FDA lists 9 510(k) clearances under the applicant name “Access Surgical Intl., Inc.” (first 1992, latest 1995), across 3 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 Access Surgical Intl., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Access Surgical Intl., Inc. is 61 days.
Which FDA product codes appear under Access Surgical Intl., Inc.?
The most frequent FDA product codes under this applicant name are GCJ (Laparoscope, General & Plastic Surgery, 6); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 2); OCZ (Endoscopic Grasping/Cutting Instrument, Non-Powered, 1).
Next steps
- See all 9 Access Surgical Intl., Inc. clearances with predicates and recalls
- Run predicate analysis for product code GCJ, Access Surgical Intl., 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.