Advanced Surgical Products, Inc.: FDA filings under this applicant name
FDA lists 64 510(k) clearances under the applicant name “Advanced Surgical Products, Inc.” (first 1987, latest 2003), across 15 product codes in 4 review panels. Median 510(k) review time under this name: 133 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 |
|---|---|---|---|
| HMX | Cannula, Ophthalmic | 29 | 29 |
| HNY | Cystotome | 6 | 6 |
| FST | Light, Surgical, Fiberoptic | 5 | 5 |
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | 5 | 5 |
| HBI | Illuminator, Fiberoptic, Surgical Field | 4 | 4 |
| GXI | Probe, Radiofrequency Lesion | 3 | 3 |
| LXP | Plug, Scleral | 3 | 3 |
| HNN | Knife, Ophthalmic | 2 | 2 |
| FPK | Tubing, Fluid Delivery | 1 | 1 |
| FZP | Clip, Implantable | 1 | 1 |
Plus 5 more product codes.
Review panels
- Ophthalmic (50)
- General and Plastic Surgery (10)
- Neurology (3)
- General Hospital (1)
Most recent Advanced Surgical Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K030926 | FAST THROW STAINLESS STEEL SURGICAL SUTURE | FZP | 2003-07-21 | 119 |
| K895800 | ADVANCED SURGICAL SOLID STATE BIPOLAR COAGULATOR | HQR | 1990-01-22 | 116 |
| K896754 | I/A HANDPIECE | HQE | 1990-01-11 | 42 |
| K896305 | MULTI-USE I/A HANDPIECE | HQE | 1989-12-18 | 49 |
| K884557 | ADVANCED SURGICAL PRODUCTS SCISSORS HANDPIECE | HQE | 1989-05-12 | 193 |
| K884556 | DREYER CURVED ENDOILLUMINATOR | HQE | 1989-02-28 | 120 |
| K890398 | RYAN-STYLE DIRECTED INFUSION MANIPULATOR | HBI | 1989-02-17 | 24 |
| K884347 | MODIFIED DISPOSABLE COAXIAL BIPOLAR PEN | GXI | 1988-12-27 | 74 |
| K883858 | FIBEROPTIC SHARP INTEGRAL PICK LIGHTPIPE | HBI | 1988-09-29 | 16 |
| K883857 | FIBEROPTIC WIRE PICK LIGHTPIPE | HBI | 1988-09-29 | 16 |
54 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Advanced Surgical Products, 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.
- Advanced Cardiovascular Systems, Inc. (103 510(k)s)
- Advanced Technology Laboratories, Inc. (61 510(k)s)
- Advanced Sterilization Products (59 510(k)s)
- Advanced Neuromodulation Systems (25 510(k)s)
- Advanced Orthopaedic Solutions, Inc. (24 510(k)s)
- Advanced Biosearch Assn. (22 510(k)s)
- Advanced Biomedical Methods, Inc. (21 510(k)s)
- Advanced Surgical, Inc. (21 510(k)s)
- Advanced Clinical Diagnostics (19 510(k)s)
- Advanced Instrumentations, Inc. (16 510(k)s)
- Advanced Instruments, Inc. (16 510(k)s)
- Advanced Spine Fixation Systems, Inc. (16 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Advanced Surgical Products, Inc.?
FDA lists 64 510(k) clearances under the applicant name “Advanced Surgical Products, Inc.” (first 1987, latest 2003), across 15 product codes in 4 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 Advanced Surgical Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Advanced Surgical Products, Inc. is 133 days.
Which FDA product codes appear under Advanced Surgical Products, Inc.?
The most frequent FDA product codes under this applicant name are HMX (Cannula, Ophthalmic, 29); HNY (Cystotome, 6); FST (Light, Surgical, Fiberoptic, 5).
Next steps
- See all 64 Advanced Surgical Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HMX, Advanced Surgical Products, 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.