Advanced Surgical Intervention, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Advanced Surgical Intervention, Inc.” (first 1988, latest 1996), across 7 product codes in 2 review panels. Median 510(k) review time under this name: 93 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 |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 2 | 2 |
| KOE | Dilator, Urethral | 2 | 2 |
| FAJ | Cystoscope And Accessories, Flexible/Rigid | 1 | 1 |
| GBM | Catheter, Urethral | 1 | 1 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 | 1 |
| KOB | Catheter, Suprapubic (And Accessories) | 1 | 1 |
| MNG | External Urethral Occluder, Urinary Incontinence-Control, Female | 1 | 1 |
Review panels
Most recent Advanced Surgical Intervention, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K954215 | MINIGUARD | MNG | 1996-05-08 | 243 |
| K926110 | ASI LIGASURE(TM) SUTURE LIGATION INSTRUMENT | GCJ | 1993-07-08 | 217 |
| K930361 | ASI CYSTOLASE LASER CYSTOSCOPE | GEX | 1993-04-29 | 93 |
| K921990 | ASI UROPLASTY LASER CYSTOSCOPE | GEX | 1992-10-28 | 183 |
| K902585 | UROPLASTY TCU PROSTATIC URETHROPLASTY CATHETER | KOE | 1990-08-27 | 76 |
| K901336 | ASI HEMOSTASIS CATHETER | GBM | 1990-06-20 | 90 |
| K896713 | ASI TCU PROSTATIC URETHROPLASTY CATHETER & ACCESS. | KOE | 1990-05-24 | 176 |
| K895182 | ASI CYSTOSCOPE SHEATH, GRASPING FORCEPS & FOR.BODY | FAJ | 1989-10-24 | 74 |
| K874530 | URETHRAL DILATOR ENDOSCOPE | KOB | 1988-01-27 | 85 |
Recalls
openFDA lists no recalls under a recalling firm named Advanced Surgical Intervention, 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 Surgical Products, Inc. (64 510(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 Medical Solutions, Ltd. (22 510(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)
Frequently asked questions
How many FDA 510(k) clearances are listed under Advanced Surgical Intervention, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Advanced Surgical Intervention, Inc.” (first 1988, latest 1996), across 7 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 Advanced Surgical Intervention, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Advanced Surgical Intervention, Inc. is 93 days.
Which FDA product codes appear under Advanced Surgical Intervention, Inc.?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 2); KOE (Dilator, Urethral, 2); FAJ (Cystoscope And Accessories, Flexible/Rigid, 1).
Next steps
- See all 9 Advanced Surgical Intervention, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Advanced Surgical Intervention, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.