Synergetics Inc
O Fallon, MO, US
SYNERGETICS, INC. appears in FDA device records in O Fallon, MO. FDA records list 18 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 37 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 18 510(k) clearances for Synergetics Inc between 1992 and 2016. The busiest year on record is 2012, with 3. The most recent is 2016, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1992 | 1 |
| 1993 | 1 |
| 1994 | 1 |
| 1997 | 1 |
| 1998 | 1 |
| 1999 | 1 |
| 2001 | 1 |
| 2002 | 1 |
| 2003 | 1 |
| 2007 | 2 |
| 2009 | 1 |
| 2011 | 1 |
| 2012 | 3 |
| 2015 | 1 |
| 2016 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K160103 | Spetzler Malis Dual Illuminating Bipolar Forceps | GEI | Substantially Equivalent | |
| K143123 | Synergetics PHOTON EX | MPA | Substantially Equivalent | |
| K121426 | AYNERGETICS DISPOSABLE SPETZLER-MALIS STANDARD BIPOLAR FORCEPS | GEI | Substantially Equivalent | |
| K121675 | VERSAVIT | HQE | Substantially Equivalent | |
| K113857 | SYNERGETICS DIRECTIONAL ENDOOCULAR LASER PROBE | HQB | Substantially Equivalent | |
| K110924 | DISPOSABLE SPETZLER-MALIS DUAL IRRIGATING BIPOLAR FORCEPS | GEI | Substantially Equivalent | |
| K091441 | SYNERGETICS ADJUSTABLE GAS PRESSURIZED INFUSION (AGPI) TUBE SET | FRN | Substantially Equivalent | |
| K071482 | STRYKER RF MULTI-LESION GENERATOR, MODEL 0406-900-000 | GXD | Substantially Equivalent | |
| K063489 | STRYKER INTRADISCAL RF GENERATOR | GXD | Substantially Equivalent | |
| K032598 | SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE | MPA | Substantially Equivalent | |
| K020220 | ULTRASONIC STRAIGHT/ULTRASONIC KNIFE/ULTRASONIC RING CURRETTE | LFL | Substantially Equivalent | |
| K010637 | SONOTOME ULTRASONIC ASPIRATOR TIPS | LFL | Substantially Equivalent | |
| K990568 | SCRAMBLED ENDOOTO LASER PROBE, STRAIGHT TIP, MODEL 59.02, SCRAMBLED ENDOOTO LASER PROBE BENT TIP, MODEL 59.01 | GEX | Substantially Equivalent | |
| K982212 | VERITAS BIPOLAR, INSULATED, 0.5MM TIP, MODEL N301-005 VERITAS BIPOLAR, INSULATED 1.0MM TIP MODEL N301-010 | GEI | Substantially Equivalent | |
| K964005 | SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE | MPA | Substantially Equivalent | |
| K932668 | OPHTHALMIC SURGICAL PNEUMATIC SCISSORS DRIVER | HQE | Substantially Equivalent | |
| K923725 | OPHTHALMIC PHARCO NEEDLE | HQC | Substantially Equivalent | |
| K923326 | OPHTHALMIC VISCOINJECTOR DRIVE | KZE | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1932402 | 1000119053 | SYNERGETICS, INC. | 3845 Corporate Centre Dr, O Fallon, MO 63368 US | 2026 | and 7 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- HQRApparatus, Cautery, Radiofrequency, Ac-Powered
- HMXCannula, Ophthalmic
- NGYCannula, Trocar, Ophthalmic
- HOCClip, Iris Retractor
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- MPAEndoilluminator
- HNRForceps, Ophthalmic
- GXDGenerator, Lesion, Radiofrequency
- KZEInjector, Fluid, Non-Electrically Powered
- MDMInstrument, Manual, Surgical, General Use
- GZXInstrument, Microsurgical
- LFLInstrument, Ultrasonic Surgical
- HQEInstrument, Vitreous Aspiration And Cutting, Ac-Powered
- HNNKnife, Ophthalmic
- HPNMagnet, Permanent
- HQBPhotocoagulator And Accessories
- GEXPowered Laser Surgical Instrument
- FRNPump, Infusion
- MRHPump, Infusion, Ophthalmic
- LRWScissors, General, Surgical
- HNFScissors, Ophthalmic
- FSMTray, Surgical, Instrument
- HQCUnit, Phacofragmentation
Recall records
Showing 25 of 37| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2254-2024 | BAUSCH+LOMB, I-PACK Injection Kit with Wire Speculum, REF 18069W, for the administration of intravitreal injection (eye) | Sterilization certificates could not be validated by the supplier | Class I | Open, Classified | |
| Z-2253-2024 | BAUSCH+LOMB, I-PACK Injection Kit Custom, REF 18069, for the administration of intravitreal injection (eye) | Sterilization certificates could not be validated by the supplier | Class I | Open, Classified | |
| Z-2252-2024 | BAUSCH+LOMB, I-PACK Injection Kit with Drape, REF 18061, for the administration of intravitreal injection (eye) | Sterilization certificates could not be validated by the supplier | Class I | Open, Classified | |
| Z-2251-2024 | BAUSCH+LOMB, I-PACK Injection Kit, REF 18060, for the administration of intravitreal injection (eye) | Sterilization certificates could not be validated by the supplier | Class I | Open, Classified | |
| Z-0122-2017 | 25 gauge VersaVit 2.0 Vitrectomy Cutter, Product/Part Number 70935, packaged in a Tyvek/Mylar double pouch configuration. | Vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification. | Class II | Terminated | |
| Z-0121-2017 | 25 gauge VersaVit 2.0 Procedure Pack with Photon Wide Field Illuminator, Product/Part Number 70025SP, packaged in HIPS rigid tray with a Tyvek lid sterile barrier system. | Vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification. | Class II | Terminated | |
| Z-0120-2017 | 25 gauge VersaVit 2.0 Procedure Pack with Mid-Field Illuminator, Product/Part Number 70025S, packaged in HIPS rigid tray with a Tyvek lid sterile barrier system. | Vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification. | Class II | Terminated | |
| Z-0119-2017 | 25 gauge VersaVit 2.0 Core Essentials Procedure Pack, Product/Part Number 70025E, packaged in HIPS rigid tray with a Tyvek lid sterile barrier system. | Vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification. | Class II | Terminated | |
| Z-0899-2014 | 25ga Aspirating Endo Illuminator, Synergetics, length 7.5 ft, sterile / EO, 56.24.25P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO. | Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure. | Class II | Terminated | |
| Z-0898-2014 | 23ga Aspirating Endo Illuminator, Synergetics, length 7.5 ft, sterile / EO, 56.24.23P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO. | Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure. | Class II | Terminated | |
| Z-0897-2014 | 25ga Mid-Field Endo Illuminator, Synergetics, length 7.5 ft, sterile / EO, 56.22.25P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO. | Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure. | Class II | Terminated | |
| Z-0896-2014 | 23ga Mid-Field Endo Illuminator, Synergetics length 7.5 ft, sterile / EO, 56.22.23P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO. | Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure. | Class II | Terminated | |
| Z-0895-2014 | Stiff 25ga Wide Field Endo Illuminator, Synergetics, inc. length 7.5 ft, sterile / EO, 56.21.25PS. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO. | Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure. | Class II | Terminated | |
| Z-0894-2014 | 23ga Wide Field Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO, 56.21.23P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO. | Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure. | Class II | Terminated | |
| Z-0893-2014 | Wide Field Endo Illuminator, Vivid (tm) Endo Illuminator, 20ga, Synergetics, inc., 20ga, length 7.5 ft, sterile / EO, 56.21P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO. | Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure. | Class II | Terminated | |
| Z-0892-2014 | Vivid (tm) Endo Illuminator, 20ga, Synergetics, inc., length 7.5 ft, sterile / EO, 56.20P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO. | Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure. | Class II | Terminated | |
| Z-0891-2014 | Two-Port Vitrectomy (TPV (tm)) Wide Field High Flow End Irrigator, Synergetics, inc., 19ga, length 7.0 ft, sterile / EO, 56.14. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO. | Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure. | Class II | Terminated | |
| Z-0890-2014 | 25ga Wide Field Corona Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO, 56.12.23P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO. | Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure. | Class II | Terminated | |
| Z-0889-2014 | 23ga Wide Field Corona Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO, 56.12.23P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO. | Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure. | Class II | Terminated | |
| Z-0888-2014 | "The Corona" Shielded Wide Field Endo Illuminator, Synergetics, inc. 20ga, length 7.0 ft, sterile / EO, 56.12. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO. | Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure. | Class II | Terminated | |
| Z-0887-2014 | 27ga ONE-STEP (tm) Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO, 56.02.27P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO. | Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure. | Class II | Terminated | |
| Z-0886-2014 | Stiff 25ga Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO, 56.02.25PS. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO. | Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure. | Class II | Terminated | |
| Z-0885-2014 | 25ga Endo Illuminator, Synergetics, inc., length 7.0 ft, sterile / EO, 56.02.25 Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO. | Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure. | Class II | Terminated | |
| Z-0884-2014 | 23ga Endo Illuminator (Eckardt Trocar Compatible), Synergetics, inc., length 8.0 ft, sterile / EO, 56.02.23P Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO. | Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure. | Class II | Terminated | |
| Z-0883-2014 | Endo Illuminator, Synergetics, inc., 20ga, length 7.0 ft, sterile / EO, 56.02. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO. | Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain