Company ยท US
Synergetics Inc
FDA 510(k) clearances and medical device recalls filed under this name, 1992 to 2016. Name variants (Inc, Corp, punctuation) are merged.
18510(k) clearances (0 in 12 months)
37recalls (0 in 12 months)
4recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HQB | Photocoagulator And Accessories | 29 |
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | 6 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 4 |
| KDD | Kit, Surgical Instrument, Disposable | 4 |
| MPA | Endoilluminator | 3 |
| GXD | Generator, Lesion, Radiofrequency | 2 |
| LFL | Instrument, Ultrasonic Surgical | 2 |
| FRN | Pump, Infusion | 1 |
| GEX | Powered Laser Surgical Instrument | 1 |
| HMX | Cannula, Ophthalmic | 1 |
| HQC | Unit, Phacofragmentation | 1 |
| KZE | Injector, Fluid, Non-Electrically Powered | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 12, 2016 | K160103 | Spetzler Malis Dual Illuminating Bipolar Forceps Synergetics | GEI |
| Feb 24, 2015 | K143123 | Synergetics PHOTON EX Synergetics | MPA |
| Jul 10, 2012 | K121426 | AYNERGETICS DISPOSABLE SPETZLER-MALIS STANDARD BIPOLAR FORCEPS Synergetics, Inc. | GEI |
| Jun 21, 2012 | K121675 | VERSAVIT Synergetics, Inc. | HQE |
| Apr 23, 2012 | K113857 | SYNERGETICS DIRECTIONAL ENDOOCULAR LASER PROBE Synergetics, Inc. | HQB |
| Dec 7, 2011 | K110924 | DISPOSABLE SPETZLER-MALIS DUAL IRRIGATING BIPOLAR FORCEPS Synergetics, Inc. | GEI |
| Oct 30, 2009 | K091441 | SYNERGETICS ADJUSTABLE GAS PRESSURIZED INFUSION (AGPI) TUBE SET Synergetics, Inc. | FRN |
| Dec 20, 2007 | K071482 | STRYKER RF MULTI-LESION GENERATOR, MODEL 0406-900-000 Synergetics, Inc. | GXD |
| May 23, 2007 | K063489 | STRYKER INTRADISCAL RF GENERATOR Synergetics, Inc. | GXD |
| Nov 24, 2003 | K032598 | SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE Synergetics, Inc. | MPA |
| Aug 23, 2002 | K020220 | ULTRASONIC STRAIGHT/ULTRASONIC KNIFE/ULTRASONIC RING CURRETTE Synergetics, Inc. | LFL |
| Apr 20, 2001 | K010637 | SONOTOME ULTRASONIC ASPIRATOR TIPS Synergetics, Inc. | LFL |
| May 14, 1999 | K990568 | SCRAMBLED ENDOOTO LASER PROBE, STRAIGHT TIP, MODEL 59.02, SCRAMBLED ENDOOTO LASER PROBE BENT TIP, MODEL 59.01 Synergetics, Inc. | GEX |
| Dec 2, 1998 | K982212 | VERITAS BIPOLAR, INSULATED, 0.5MM TIP, MODEL N301-005 VERITAS BIPOLAR, INSULATED 1.0MM TIP MODEL N301-010 Synergetics, Inc. | GEI |
| Jun 9, 1997 | K964005 | SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE Synergetics, Inc. | MPA |
| Feb 23, 1994 | K932668 | OPHTHALMIC SURGICAL PNEUMATIC SCISSORS DRIVER Synergetics, Inc. | HQE |
| Mar 18, 1993 | K923725 | OPHTHALMIC PHARCO NEEDLE Synergetics, Inc. | HQC |
| Sep 30, 1992 | K923326 | OPHTHALMIC VISCOINJECTOR DRIVE Synergetics, Inc. | KZE |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 11, 2024 | Synergetics Inc BAUSCH+LOMB, I-PACK Injection Kit with Wire Speculum, REF 18069W, for the administration of intravitreal injection (eye) Open, Classified |
KDD | None listed |
| Jul 11, 2024 | Synergetics Inc BAUSCH+LOMB, I-PACK Injection Kit Custom, REF 18069, for the administration of intravitreal injection (eye) Open, Classified |
KDD | None listed |
| Jul 11, 2024 | Synergetics Inc BAUSCH+LOMB, I-PACK Injection Kit with Drape, REF 18061, for the administration of intravitreal injection (eye) Open, Classified |
KDD | None listed |
| Jul 11, 2024 | Synergetics Inc BAUSCH+LOMB, I-PACK Injection Kit, REF 18060, for the administration of intravitreal injection (eye) Open, Classified |
KDD | None listed |
| Oct 18, 2016 | Synergetics Inc 25 gauge VersaVit 2.0 Vitrectomy Cutter, Product/Part Number 70935, packaged in a Tyvek/Mylar double pouch configuration. Terminated |
HQE | K121675 |
| Oct 18, 2016 | Synergetics Inc 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. Terminated |
HQE | K121675 |
| Oct 18, 2016 | Synergetics Inc 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. Terminated |
HQE | K121675 |
| Oct 18, 2016 | Synergetics Inc 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. Terminated |
HQE | K121675 |
| Jan 30, 2014 | Synergetics Inc 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. Terminated |
HQB | None listed |
| Jan 30, 2014 | Synergetics Inc 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. Terminated |
HQB | None listed |
| Jan 30, 2014 | Synergetics Inc 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. Terminated |
HQB | None listed |
| Jan 30, 2014 | Synergetics Inc 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. Terminated |
HQB | None listed |
| Jan 30, 2014 | Synergetics Inc 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. Terminated |
HQB | None listed |
| Jan 30, 2014 | Synergetics Inc 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. Terminated |
HQB | None listed |
| Jan 30, 2014 | Synergetics Inc 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. Terminated |
HQB | None listed |
| Jan 30, 2014 | Synergetics Inc 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. Terminated |
HQB | None listed |
| Jan 30, 2014 | Synergetics Inc 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, M Terminated |
HQB | None listed |
| Jan 30, 2014 | Synergetics Inc 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. Terminated |
HQB | None listed |
| Jan 30, 2014 | Synergetics Inc 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. Terminated |
HQB | None listed |
| Jan 30, 2014 | Synergetics Inc "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. Terminated |
HQB | None listed |
| Jan 30, 2014 | Synergetics Inc 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. Terminated |
HQB | None listed |
| Jan 30, 2014 | Synergetics Inc 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. Terminated |
HQB | None listed |
| Jan 30, 2014 | Synergetics Inc 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. Terminated |
HQB | None listed |
| Jan 30, 2014 | Synergetics Inc 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. Terminated |
HQB | None listed |
| Jan 30, 2014 | Synergetics Inc 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. Terminated |
HQB | None listed |
| Jan 30, 2014 | Synergetics Inc 23ga Straight Fixed Extended Illuminated Laser Probe, Synergetics, length 7.5 ft, sterile / EO, 55.62.23P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO. Terminated |
HQB | None listed |
| Jan 30, 2014 | Synergetics Inc 27ga ONE-STEP (tm) Awh/Tano Vivid Chandelier, Synergetics, length 8.0 ft, sterile / EO, 56.55.27P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO. Terminated |
HQB | None listed |
| Jan 30, 2014 | Synergetics Inc 25ga Awh Vivid Chandelier, Synergetics, length 7.5 ft, sterile / EO, 56.54.25P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO. Terminated |
HQB | None listed |
| Jan 30, 2014 | Synergetics Inc 25ga Awh Chandelier, Synergetics, inc., B&L Cannula Compatible, length 8.0 ft, sterile / EO, 56.52.25P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO. Terminated |
HQB | None listed |
| Jan 30, 2014 | Synergetics Inc 29ga Oshima Dual Chandelier, Synergetics, inc., length 7.5 ft, sterile / EO, 56.50.29P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO. Terminated |
HQB | None listed |
| Jan 30, 2014 | Synergetics Inc 25ga Awh Chandelier, Synergetics, inc., length 8.0 ft, sterile / EO, 56.50.25P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO. Terminated |
HQB | None listed |
| Jan 30, 2014 | Synergetics Inc 23ga Chandelier Infusion Cannula, Synergetics, inc., length 8.0 ft, sterile / EO, 56.30.23P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO. Terminated |
HQB | None listed |
| Jan 30, 2014 | Synergetics Inc Chandelier Infusion Cannula, Synergetics, inc., 20ga, length 7.5 ft, sterile / EO, 56.30.P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO. Terminated |
HQB | None listed |
| Jan 30, 2014 | Synergetics Inc Stiff 25ga Chow Illuminated Pick (Dull), Synergetics, inc., length 8.0 ft, sterile / EO, 56.07.25PS. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO. Terminated |
HQB | None listed |
| Jan 30, 2014 | Synergetics Inc 23ga Chow Illuminated Pick, Synergetics, inc., length 7.5 ft, sterile / EO, 56.07.23P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO. Terminated |
HQB | None listed |
| Jan 30, 2014 | Synergetics Inc Standard tubing set, Synergetics, Inc., length 10 ft, sterile / EO, 17570. Packed 6 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO. Terminated |
HQB | None listed |
| Oct 22, 2013 | Synergetics Inc Synergetics 25 gauge Soft Tip Cannula, packaged in 6 units per box. Catalog number: 30.08.25.
Single-use 25 gauge cannula used in vitreoretinal surgery. Terminated |
HMX | None listed |