Synergetics, Inc.: FDA filings under this applicant name
FDA lists 18 510(k) clearances under the applicant name “Synergetics, Inc.” (first 1992, latest 2016), across 10 product codes in 4 review panels. Median 510(k) review time under this name: 165 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 3 | 57 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 1 | 116 |
| 2016 | 1 | 267 |
| 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 |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 4 | 4 |
| MPA | Endoilluminator | 3 | 3 |
| GXD | Generator, Lesion, Radiofrequency | 2 | 2 |
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | 2 | 2 |
| LFL | Instrument, Ultrasonic Surgical | 2 | 2 |
| FRN | Pump, Infusion | 1 | 1 |
| GEX | Powered Laser Surgical Instrument | 1 | 1 |
| HQB | Photocoagulator And Accessories | 1 | 1 |
| HQC | Unit, Phacofragmentation | 1 | 1 |
| KZE | Injector, Fluid, Non-Electrically Powered | 1 | 1 |
Review panels
- Ophthalmic (7)
- General and Plastic Surgery (7)
- General Hospital (2)
- Neurology (2)
Most recent Synergetics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K160103 | Spetzler Malis Dual Illuminating Bipolar Forceps | GEI | 2016-10-12 | 267 |
| K143123 | Synergetics PHOTON EX | MPA | 2015-02-24 | 116 |
| K121426 | AYNERGETICS DISPOSABLE SPETZLER-MALIS STANDARD BIPOLAR FORCEPS | GEI | 2012-07-10 | 57 |
| K121675 | VERSAVIT | HQE | 2012-06-21 | 15 |
| K113857 | SYNERGETICS DIRECTIONAL ENDOOCULAR LASER PROBE | HQB | 2012-04-23 | 115 |
| K110924 | DISPOSABLE SPETZLER-MALIS DUAL IRRIGATING BIPOLAR FORCEPS | GEI | 2011-12-07 | 247 |
| K091441 | SYNERGETICS ADJUSTABLE GAS PRESSURIZED INFUSION (AGPI) TUBE SET | FRN | 2009-10-30 | 168 |
| K071482 | STRYKER RF MULTI-LESION GENERATOR, MODEL 0406-900-000 | GXD | 2007-12-20 | 204 |
| K063489 | STRYKER INTRADISCAL RF GENERATOR | GXD | 2007-05-23 | 187 |
| K032598 | SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE | MPA | 2003-11-24 | 91 |
8 earlier clearances. See the full list in Caduvo.
Recalls
37 product recalls in 4 recall events; 4 initiated in the last five years. Most recent: 2024-06-12.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Synergetics, Inc. (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
Frequently asked questions
How many FDA 510(k) clearances are listed under Synergetics, Inc.?
FDA lists 18 510(k) clearances under the applicant name “Synergetics, Inc.” (first 1992, latest 2016), across 10 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Synergetics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Synergetics, Inc. is 165 days.
Which FDA product codes appear under Synergetics, Inc.?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 4); MPA (Endoilluminator, 3); GXD (Generator, Lesion, Radiofrequency, 2).
Next steps
- See all 18 Synergetics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEI, Synergetics, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.