Site Microsurgical Systems, Inc.: FDA filings under this applicant name
FDA lists 30 510(k) clearances under the applicant name “Site Microsurgical Systems, Inc.” (first 1986, latest 1994), across 10 product codes in 4 review panels. Median 510(k) review time under this name: 66 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 |
|---|---|---|---|
| HQC | Unit, Phacofragmentation | 14 | 14 |
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | 7 | 7 |
| KYG | Device, Irrigation, Ocular Surgery | 2 | 2 |
| EBW | Controller, Foot, Handpiece And Cord | 1 | 1 |
| FCT | Headlight, Fiberoptic Focusing | 1 | 1 |
| FPA | Set, Administration, Intravascular | 1 | 1 |
| GEX | Powered Laser Surgical Instrument | 1 | 1 |
| HJO | Biomicroscope, Slit-Lamp, Ac-Powered | 1 | 1 |
| HMG | Stand, Instrument, Ophthalmic, Non-Powered | 1 | 1 |
| LRP | Tray, Surgical | 1 | 1 |
Review panels
- Ophthalmic (26)
- General and Plastic Surgery (2)
- Dental (1)
- General Hospital (1)
Most recent Site Microsurgical Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K925828 | MODIFIED SITE TXR SYSTEMS | HQC | 1994-02-16 | 457 |
| K925921 | MODIFIED SITE DISPOSABLE DIAPHRAGM CASSETTE | KYG | 1993-12-06 | 378 |
| K931866 | SITE'S CD II PHACOEMULSIFICATION HANDPIECE | HQC | 1993-11-12 | 212 |
| K921135 | IOLAB POWER I.V. POLE | HQC | 1992-06-03 | 85 |
| K920582 | 180 TIP, 1/A HANDPIECE .3MM END OPENING FOR OPHT. | HQE | 1992-05-08 | 88 |
| K912902 | PHACOEMULSIFICATION SYSTEM FOR OPHTHALMIC USE | HQC | 1991-12-17 | 168 |
| K912739 | SITE 90 TIP, I/A HANDPIECE .3MM SIDE OPEN/OPTH USE | HQC | 1991-08-28 | 68 |
| K910980 | SITE 20 GAUGE REUSABLE FIBER OPTIC CABLE | HJO | 1991-05-22 | 76 |
| K905620 | MODIFIED SITE PERISTALTIC FOOTSWITCH | EBW | 1991-02-27 | 75 |
| K904183 | SITE PHACOEMULSIFICATION HANDPIECE | HQC | 1990-12-05 | 84 |
20 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Site Microsurgical Systems, 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.
- Site Saver, Inc. D/B/A Lineus Medical (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Site Microsurgical Systems, Inc.?
FDA lists 30 510(k) clearances under the applicant name “Site Microsurgical Systems, Inc.” (first 1986, latest 1994), across 10 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 Site Microsurgical Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Site Microsurgical Systems, Inc. is 66 days.
Which FDA product codes appear under Site Microsurgical Systems, Inc.?
The most frequent FDA product codes under this applicant name are HQC (Unit, Phacofragmentation, 14); HQE (Instrument, Vitreous Aspiration And Cutting, Ac-Powered, 7); KYG (Device, Irrigation, Ocular Surgery, 2).
Next steps
- See all 30 Site Microsurgical Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HQC, Site Microsurgical Systems, 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.