Surgeon Surgical Instrumentation, Inc.
Mchenry, IL, US
Surgeon Surgical Instrumentation, Inc. appears in FDA device records in Mchenry, IL. FDA records list 10 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 10
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 10 510(k) clearances for Surgeon Surgical Instrumentation, Inc. between 1983 and 1995. The busiest year on record is 1988, with 2. The most recent is 1995, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1983 | 1 |
| 1985 | 1 |
| 1986 | 1 |
| 1988 | 2 |
| 1989 | 1 |
| 1990 | 1 |
| 1992 | 1 |
| 1993 | 1 |
| 1995 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K954241 | SURGIN GENISIS PHACOEMULSIFIER | HQC | Substantially Equivalent | |
| K932281 | VERRES NEEDLE | GCT | Substantially Equivalent | |
| K922038 | CO2 INSUFFLATION TUBING | HIF | Substantially Equivalent | |
| K904010 | SURGICAL ASPIRATOR KIT | LFL | Substantially Equivalent | |
| K890447 | HEMORRHAGE OCCLUDOR | GDW | Substantially Equivalent | |
| K880543 | UNI-PORT | KYG | Substantially Equivalent | |
| K881232 | SURGIN EYE SHIELD | HOY | Substantially Equivalent | |
| K861203 | MULTI-SPIKE | KYG | Substantially Equivalent | |
| K852229 | STERILE EYE PACKS OR TRAYS | Substantially Equivalent | ||
| K830859 | I/A KIT | GBX | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- GBXCatheter, Irrigation
- KYGDevice, Irrigation, Ocular Surgery
- LFLInstrument, Ultrasonic Surgical
- HIFInsufflator, Laparoscopic
- GCTLight Source, Endoscope, Xenon Arc
- HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
- GDWStaple, Implantable
- HQCUnit, Phacofragmentation
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain