Surgeon Surgical Instrumentation, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Surgeon Surgical Instrumentation, Inc.” (first 1983, latest 1995), across 9 product codes in 4 review panels. Median 510(k) review time under this name: 64 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 |
|---|---|---|---|
| KYG | Device, Irrigation, Ocular Surgery | 2 | 2 |
| GBX | Catheter, Irrigation | 1 | 1 |
| GCT | Light Source, Endoscope, Xenon Arc | 1 | 1 |
| GDW | Staple, Implantable | 1 | 1 |
| HIF | Insufflator, Laparoscopic | 1 | 1 |
| HOY | Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | 1 | 1 |
| HQC | Unit, Phacofragmentation | 1 | 1 |
| LFL | Instrument, Ultrasonic Surgical | 1 | 1 |
Plus 1 more product codes.
Review panels
- Ophthalmic (4)
- General and Plastic Surgery (3)
- Gastroenterology and Urology (1)
- Obstetrics and Gynecology (1)
Most recent Surgeon Surgical Instrumentation, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K954241 | SURGIN GENISIS PHACOEMULSIFIER | HQC | 1995-12-01 | 81 |
| K932281 | VERRES NEEDLE | GCT | 1993-08-06 | 86 |
| K922038 | CO2 INSUFFLATION TUBING | HIF | 1992-10-13 | 165 |
| K904010 | SURGICAL ASPIRATOR KIT | LFL | 1990-11-21 | 84 |
| K890447 | HEMORRHAGE OCCLUDOR | GDW | 1989-02-23 | 27 |
| K880543 | UNI-PORT | KYG | 1988-07-01 | 143 |
| K881232 | SURGIN EYE SHIELD | HOY | 1988-04-13 | 22 |
| K861203 | MULTI-SPIKE | KYG | 1986-04-28 | 27 |
| K852229 | STERILE EYE PACKS OR TRAYS | — | 1985-06-07 | 16 |
| K830859 | I/A KIT | GBX | 1983-05-02 | 46 |
Recalls
openFDA lists no recalls under a recalling firm named Surgeon Surgical Instrumentation, 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.
- Surgeon Design (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Surgeon Surgical Instrumentation, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Surgeon Surgical Instrumentation, Inc.” (first 1983, latest 1995), across 9 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 Surgeon Surgical Instrumentation, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Surgeon Surgical Instrumentation, Inc. is 64 days.
Which FDA product codes appear under Surgeon Surgical Instrumentation, Inc.?
The most frequent FDA product codes under this applicant name are KYG (Device, Irrigation, Ocular Surgery, 2); GBX (Catheter, Irrigation, 1); GCT (Light Source, Endoscope, Xenon Arc, 1).
Next steps
- See all 10 Surgeon Surgical Instrumentation, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KYG, Surgeon Surgical Instrumentation, 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.