Advanced Surgical, Inc.: FDA filings under this applicant name
FDA lists 21 510(k) clearances under the applicant name “Advanced Surgical, Inc.” (first 1992, latest 1995), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 111 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 | 18 | 18 |
| DQX | Wire, Guide, Catheter | 1 | 1 |
| FMF | Syringe, Piston | 1 | 1 |
| KGX | Tape And Bandage, Adhesive | 1 | 1 |
Review panels
Most recent Advanced Surgical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K950126 | ENDOSCOPIC LIGATION DEVICE, LIGATOR HANDLE, LIGATOR CARTRIDGE | GCJ | 1995-04-13 | 91 |
| K950005 | TROCAR CANNULA STABILIZER | GCJ | 1995-01-18 | 15 |
| K945369 | LAPAROSCOPIC SURGICAL INSTRUMENTS FOR GENERAL USE | GCJ | 1994-11-22 | 89 |
| K933497 | LAPAROSCOPIC COVERED SURGICAL RETRACTOR | GCJ | 1994-05-12 | 297 |
| K941500 | TISSUE ISOLATION AND RETRIEVAL BAG | GCJ | 1994-04-19 | 21 |
| K931850 | VERRSS PNEUMO NEEDLE | GCJ | 1994-04-07 | 359 |
| K934807 | PUNCTURE CLOSURE DEVICE | GCJ | 1994-03-01 | 145 |
| K932540 | LAPORASCOPIC SURGICAL INSTRUMENTS /GENERAL USE | GCJ | 1994-02-17 | 267 |
| K940193 | SURGICAL RETRACTOR KIT | GCJ | 1994-02-15 | 33 |
| K935878 | GLASSER SUTURE NEEDLE | GCJ | 1994-02-09 | 62 |
11 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Advanced Surgical, 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 Clinical Diagnostics (19 510(k)s)
- Advanced Instrumentations, Inc. (16 510(k)s)
- Advanced Instruments, Inc. (16 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Advanced Surgical, Inc.?
FDA lists 21 510(k) clearances under the applicant name “Advanced Surgical, Inc.” (first 1992, latest 1995), across 4 product codes in 3 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, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Advanced Surgical, Inc. is 111 days.
Which FDA product codes appear under Advanced Surgical, Inc.?
The most frequent FDA product codes under this applicant name are GCJ (Laparoscope, General & Plastic Surgery, 18); DQX (Wire, Guide, Catheter, 1); FMF (Syringe, Piston, 1).
Next steps
- See all 21 Advanced Surgical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GCJ, Advanced Surgical, 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.