Company ยท US
Site Microsurgical Systems, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1986 to 1994. Name variants (Inc, Corp, punctuation) are merged.
30510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HQC | Unit, Phacofragmentation | 14 |
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | 7 |
| KYG | Device, Irrigation, Ocular Surgery | 2 |
| EBW | Controller, Foot, Handpiece And Cord | 1 |
| FCT | Headlight, Fiberoptic Focusing | 1 |
| FPA | Set, Administration, Intravascular | 1 |
| GEX | Powered Laser Surgical Instrument | 1 |
| HJO | Biomicroscope, Slit-Lamp, Ac-Powered | 1 |
| HMG | Stand, Instrument, Ophthalmic, Non-Powered | 1 |
| LRP | Tray, Surgical | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 16, 1994 | K925828 | MODIFIED SITE TXR SYSTEMS Site Microsurgical Systems, Inc. | HQC |
| Dec 6, 1993 | K925921 | MODIFIED SITE DISPOSABLE DIAPHRAGM CASSETTE Site Microsurgical Systems, Inc. | KYG |
| Nov 12, 1993 | K931866 | SITE'S CD II PHACOEMULSIFICATION HANDPIECE Site Microsurgical Systems, Inc. | HQC |
| Jun 3, 1992 | K921135 | IOLAB POWER I.V. POLE Site Microsurgical Systems, Inc. | HQC |
| May 8, 1992 | K920582 | 180 TIP, 1/A HANDPIECE .3MM END OPENING FOR OPHT. Site Microsurgical Systems, Inc. | HQE |
| Dec 17, 1991 | K912902 | PHACOEMULSIFICATION SYSTEM FOR OPHTHALMIC USE Site Microsurgical Systems, Inc. | HQC |
| Aug 28, 1991 | K912739 | SITE 90 TIP, I/A HANDPIECE .3MM SIDE OPEN/OPTH USE Site Microsurgical Systems, Inc. | HQC |
| May 22, 1991 | K910980 | SITE 20 GAUGE REUSABLE FIBER OPTIC CABLE Site Microsurgical Systems, Inc. | HJO |
| Feb 27, 1991 | K905620 | MODIFIED SITE PERISTALTIC FOOTSWITCH Site Microsurgical Systems, Inc. | EBW |
| Dec 5, 1990 | K904183 | SITE PHACOEMULSIFICATION HANDPIECE Site Microsurgical Systems, Inc. | HQC |
| Dec 5, 1990 | K904151 | SITE 19 GAUGE ULTRASONIC I/A PHACO NEEDLE Site Microsurgical Systems, Inc. | HQC |
| Nov 21, 1990 | K904186 | SITE DIAPHRAGM CASSETTE Site Microsurgical Systems, Inc. | KYG |
| Mar 8, 1990 | K896943 | SITE DISPOSABLE CUTTER AND ACCESSORIES Site Microsurgical Systems, Inc. | HQE |
| Dec 4, 1989 | K895663 | SITE 810E PHOTOCOAGULATOR AND ACCESSORIES Site Microsurgical Systems, Inc. | GEX |
| Jun 8, 1989 | K892852 | SITE PHACO PLUS INFUSION SLEEVE Site Microsurgical Systems, Inc. | HQC |
| May 17, 1989 | K892911 | SITE PERISTALTIC CASSETTE Site Microsurgical Systems, Inc. | HQC |
| Nov 15, 1988 | K883926 | .2MM, .4MM, .5MM IRRIGATION AND ASPIRATION HAND. Site Microsurgical Systems, Inc. | HQE |
| Oct 25, 1988 | K883975 | DISP. 20 GAUGE SITE FIBER OPTIC CABLE & ILLUMI. Site Microsurgical Systems, Inc. | HQE |
| Oct 25, 1988 | K883605 | MODIFIED REUSABLE SITE FIBER OPTIC CABLE Site Microsurgical Systems, Inc. | HQE |
| Sep 15, 1988 | K883099 | SITE MACROBORE PHACO NEEDLE Site Microsurgical Systems, Inc. | HQC |
| Sep 12, 1988 | K883575 | MODIFIED SITE MOBILE STAND FOR OPHTHALMIC USE Site Microsurgical Systems, Inc. | HMG |
| Aug 24, 1988 | K883480 | MODIFIED SITE FIBER OPTIC MODULE FOR OPHTHAL. USE Site Microsurgical Systems, Inc. | FCT |
| Aug 18, 1988 | K883098 | SITE STERILIZATION TRAYS FOR OPHTHALMIC USE Site Microsurgical Systems, Inc. | LRP |
| Jul 1, 1988 | K882103 | SITE ULTRASONIC I/A PHACO NEEDLE Site Microsurgical Systems, Inc. | HQC |
| Apr 1, 1988 | K874725 | SITE SOLUTION ADMINISTRATION SET Site Microsurgical Systems, Inc. | FPA |
| Jun 3, 1987 | K871485 | SITE PHACOEMULSIFICATION SYSTEM/OPHTHALMIC USE Site Microsurgical Systems, Inc. | HQC |
| May 7, 1987 | K871375 | SITE PERISTALTIC MODULE SYSTEM Site Microsurgical Systems, Inc. | HQE |
| Dec 15, 1986 | K864301 | SITE PHACOEMULSIFICATION SYST/OPHTHALMIC USE (MOD) Site Microsurgical Systems, Inc. | HQC |
| Aug 21, 1986 | K862943 | SITE DISPOSABLE FIBEROPTIC ILLUMINATOR AND CABLE Site Microsurgical Systems, Inc. | HQE |
| May 6, 1986 | K861060 | SITE PHACO DISPOSABLE CASSETTE Site Microsurgical Systems, Inc. | HQC |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||