Surgin Surgical Instrumentation, Inc.: FDA clearances and approvals
Surgin Surgical Instrumentation, Inc. has 23 FDA 510(k) clearances (first 1993, latest 2009), across 10 product codes in 3 review panels. Median 510(k) review time: 88 days.
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 |
|---|---|---|---|
| HQC | Unit, Phacofragmentation | 8 | 8 |
| GCJ | Laparoscope, General & Plastic Surgery | 4 | 4 |
| HNO | Keratome, Ac-Powered | 4 | 4 |
| FMG | Stopcock, I.V. Set | 1 | 1 |
| FSA | Lift, Patient, Non-Ac-Powered | 1 | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| HOZ | Sponge, Ophthalmic | 1 | 1 |
| HQZ | Frame, Spectacle | 1 | 1 |
| MDM | Instrument, Manual, Surgical, General Use | 1 | 1 |
| MSR | Tubing, Replacement, Phacofragmentation Unit | 1 | 1 |
Review panels
Most recent Surgin Surgical Instrumentation, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K082110 | DUAL SYRINGE HOLDER | FMG | 2009-06-17 | 324 |
| K033236 | PRIZM KERATOME BLADE, MODEL MK8512M2 | HNO | 2004-03-26 | 172 |
| K033182 | PRIZM KERATOME BLADE (B.D. MODEL), MODEL MK8530BD | HNO | 2004-01-30 | 121 |
| K011195 | PRIZM BLADE (MORIA MODEL) LSK / MK8510LSK; PRIZM BLADE (MORIA MODEL) CB / MK8511CB | HNO | 2001-11-06 | 201 |
| K994015 | ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL), MK8508 | HNO | 2000-03-15 | 110 |
| K980849 | SURGIN KIT | MSR | 1998-07-09 | 154 |
| K954238 | SURGIN GENISIS HANDPIECE | HQC | 1995-12-08 | 88 |
| K950600 | VACUUM SURGE SUPRESSER | HQC | 1995-05-10 | 90 |
| K942945 | CASSETTE SYSTEM FOR STORZ | HQC | 1994-12-05 | 166 |
| K942944 | IRRIGATION/BIPOLAR SET | GEI | 1994-09-27 | 97 |
13 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Surgin Surgical Instrumentation, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Surgin Surgical Instrumentation, Inc. have?
Surgin Surgical Instrumentation, Inc. has 23 FDA 510(k) clearances (first 1993, latest 2009), across 10 product codes in 3 review panels.
How long does FDA take to clear Surgin Surgical Instrumentation, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Surgin Surgical Instrumentation, Inc.'s cleared 510(k)s is 88 days.
What devices does Surgin Surgical Instrumentation, Inc. make?
Its most frequent FDA product codes are HQC (Unit, Phacofragmentation, 8); GCJ (Laparoscope, General & Plastic Surgery, 4); HNO (Keratome, Ac-Powered, 4).
Has Surgin Surgical Instrumentation, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Surgin Surgical Instrumentation, Inc. Related entities may recall under other names.
Next steps
- See all 23 Surgin Surgical Instrumentation, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HQC, Surgin Surgical Instrumentation, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.