Company ยท US
Surgin Surgical Instrumentation, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1993 to 2009. Name variants (Inc, Corp, punctuation) are merged.
23510(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 | 8 |
| GCJ | Laparoscope, General & Plastic Surgery | 4 |
| HNO | Keratome, Ac-Powered | 4 |
| FMG | Stopcock, I.V. Set | 1 |
| FSA | Lift, Patient, Non-Ac-Powered | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 |
| HOZ | Sponge, Ophthalmic | 1 |
| HQZ | Frame, Spectacle | 1 |
| MDM | Instrument, Manual, Surgical, General Use | 1 |
| MSR | Tubing, Replacement, Phacofragmentation Unit | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 17, 2009 | K082110 | DUAL SYRINGE HOLDER Surgin Surgical Instrumentation, Inc. | FMG |
| Mar 26, 2004 | K033236 | PRIZM KERATOME BLADE, MODEL MK8512M2 Surgin Surgical Instrumentation, Inc. | HNO |
| Jan 30, 2004 | K033182 | PRIZM KERATOME BLADE (B.D. MODEL), MODEL MK8530BD Surgin Surgical Instrumentation, Inc. | HNO |
| Nov 6, 2001 | K011195 | PRIZM BLADE (MORIA MODEL) LSK / MK8510LSK; PRIZM BLADE (MORIA MODEL) CB / MK8511CB Surgin Surgical Instrumentation, Inc. | HNO |
| Mar 15, 2000 | K994015 | ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL), MK8508 Surgin Surgical Instrumentation, Inc. | HNO |
| Jul 9, 1998 | K980849 | SURGIN KIT Surgin Surgical Instrumentation, Inc. | MSR |
| Dec 8, 1995 | K954238 | SURGIN GENISIS HANDPIECE Surgin Surgical Instrumentation, Inc. | HQC |
| May 10, 1995 | K950600 | VACUUM SURGE SUPRESSER Surgin Surgical Instrumentation, Inc. | HQC |
| Dec 5, 1994 | K942945 | CASSETTE SYSTEM FOR STORZ Surgin Surgical Instrumentation, Inc. | HQC |
| Sep 27, 1994 | K942944 | IRRIGATION/BIPOLAR SET Surgin Surgical Instrumentation, Inc. | GEI |
| Aug 5, 1994 | K942897 | OPTHALMIC WIPE Surgin Surgical Instrumentation, Inc. | HQZ |
| Aug 2, 1994 | K942807 | SURGICAL LIFT SHEET Surgin Surgical Instrumentation, Inc. | FSA |
| Jul 28, 1994 | K943102 | HIGH PERFORMANCE TIPS Surgin Surgical Instrumentation, Inc. | HQC |
| Jul 25, 1994 | K942518 | CASSETTE SYSTEM FOR SITE Surgin Surgical Instrumentation, Inc. | HQC |
| Jul 25, 1994 | K942517 | 10-K CASSETTE Surgin Surgical Instrumentation, Inc. | HQC |
| Jul 25, 1994 | K942516 | 10-0 CASSETTE Surgin Surgical Instrumentation, Inc. | HQC |
| Jul 25, 1994 | K942515 | PHACO KIT Surgin Surgical Instrumentation, Inc. | HQC |
| Jul 22, 1994 | K943070 | REUSABLE PROBES Surgin Surgical Instrumentation, Inc. | GCJ |
| Jul 19, 1994 | K942896 | CLAMPS AND CLIPS Surgin Surgical Instrumentation, Inc. | MDM |
| Jul 15, 1994 | K942642 | SURGI-WIPE Surgin Surgical Instrumentation, Inc. | HOZ |
| Jul 7, 1994 | K942641 | SURGIN IRRIGATION PUMP Surgin Surgical Instrumentation, Inc. | GCJ |
| Feb 15, 1994 | K935293 | FLUID ASPIRATION NEEDLE Surgin Surgical Instrumentation, Inc. | GCJ |
| Dec 1, 1993 | K934173 | SUTURE HANDLER Surgin Surgical Instrumentation, Inc. | GCJ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||