Site Microsurgical Systems, Inc.
Horsham, PA, US
Site Microsurgical Systems, Inc. appears in FDA device records in Horsham, PA. FDA records list 30 510(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
- 30
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 30 510(k) clearances for Site Microsurgical Systems, Inc. between 1986 and 1994. The busiest year on record is 1988, with 9. The most recent is 1994, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1986 | 3 |
| 1987 | 2 |
| 1988 | 9 |
| 1989 | 3 |
| 1990 | 4 |
| 1991 | 4 |
| 1992 | 2 |
| 1993 | 2 |
| 1994 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K925828 | MODIFIED SITE TXR SYSTEMS | HQC | Substantially Equivalent | |
| K925921 | MODIFIED SITE DISPOSABLE DIAPHRAGM CASSETTE | KYG | Substantially Equivalent | |
| K931866 | SITE'S CD II PHACOEMULSIFICATION HANDPIECE | HQC | Substantially Equivalent | |
| K921135 | IOLAB POWER I.V. POLE | HQC | Substantially Equivalent | |
| K920582 | 180 TIP, 1/A HANDPIECE .3MM END OPENING FOR OPHT. | HQE | Substantially Equivalent | |
| K912902 | PHACOEMULSIFICATION SYSTEM FOR OPHTHALMIC USE | HQC | Substantially Equivalent | |
| K912739 | SITE 90 TIP, I/A HANDPIECE .3MM SIDE OPEN/OPTH USE | HQC | Substantially Equivalent | |
| K910980 | SITE 20 GAUGE REUSABLE FIBER OPTIC CABLE | HJO | Substantially Equivalent | |
| K905620 | MODIFIED SITE PERISTALTIC FOOTSWITCH | EBW | Substantially Equivalent | |
| K904183 | SITE PHACOEMULSIFICATION HANDPIECE | HQC | Substantially Equivalent | |
| K904151 | SITE 19 GAUGE ULTRASONIC I/A PHACO NEEDLE | HQC | Substantially Equivalent | |
| K904186 | SITE DIAPHRAGM CASSETTE | KYG | Substantially Equivalent | |
| K896943 | SITE DISPOSABLE CUTTER AND ACCESSORIES | HQE | Substantially Equivalent | |
| K895663 | SITE 810E PHOTOCOAGULATOR AND ACCESSORIES | GEX | Substantially Equivalent | |
| K892852 | SITE PHACO PLUS INFUSION SLEEVE | HQC | Substantially Equivalent | |
| K892911 | SITE PERISTALTIC CASSETTE | HQC | Substantially Equivalent | |
| K883926 | .2MM, .4MM, .5MM IRRIGATION AND ASPIRATION HAND. | HQE | Substantially Equivalent | |
| K883975 | DISP. 20 GAUGE SITE FIBER OPTIC CABLE & ILLUMI. | HQE | Substantially Equivalent | |
| K883605 | MODIFIED REUSABLE SITE FIBER OPTIC CABLE | HQE | Substantially Equivalent | |
| K883099 | SITE MACROBORE PHACO NEEDLE | HQC | Substantially Equivalent | |
| K883575 | MODIFIED SITE MOBILE STAND FOR OPHTHALMIC USE | HMG | Substantially Equivalent | |
| K883480 | MODIFIED SITE FIBER OPTIC MODULE FOR OPHTHAL. USE | FCT | Substantially Equivalent | |
| K883098 | SITE STERILIZATION TRAYS FOR OPHTHALMIC USE | LRP | Substantially Equivalent | |
| K882103 | SITE ULTRASONIC I/A PHACO NEEDLE | HQC | Substantially Equivalent | |
| K874725 | SITE SOLUTION ADMINISTRATION SET | FPA | Substantially Equivalent | |
| K871485 | SITE PHACOEMULSIFICATION SYSTEM/OPHTHALMIC USE | HQC | Substantially Equivalent | |
| K871375 | SITE PERISTALTIC MODULE SYSTEM | HQE | Substantially Equivalent | |
| K864301 | SITE PHACOEMULSIFICATION SYST/OPHTHALMIC USE (MOD) | HQC | Substantially Equivalent | |
| K862943 | SITE DISPOSABLE FIBEROPTIC ILLUMINATOR AND CABLE | HQE | Substantially Equivalent | |
| K861060 | SITE PHACO DISPOSABLE CASSETTE | HQC | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- HJOBiomicroscope, Slit-Lamp, Ac-Powered
- EBWController, Foot, Handpiece And Cord
- KYGDevice, Irrigation, Ocular Surgery
- FCTHeadlight, Fiberoptic Focusing
- HQEInstrument, Vitreous Aspiration And Cutting, Ac-Powered
- GEXPowered Laser Surgical Instrument
- FPASet, Administration, Intravascular
- HMGStand, Instrument, Ophthalmic, Non-Powered
- LRPTray, Surgical
- 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