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Synergetics Inc

FDA Regulatory Profile

Synergetics Inc appears in FDA public data with 37 recalls — including 4 Class I (most serious) —, 18 510(k) clearances, 9 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2253-2024, Class I) was initiated on June 12, 2024. Its most recent 510(k) clearance was granted on October 12, 2016.

Summary

Total Recalls
37 (4 Class I)
510(k) Clearances
18
Inspections
9
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2253-2024Class IBAUSCH+LOMB, I-PACK Injection Kit Custom, REF 18069, for the administration of intravitreal injectiJune 12, 2024
Z-2254-2024Class IBAUSCH+LOMB, I-PACK Injection Kit with Wire Speculum, REF 18069W, for the administration of intraviJune 12, 2024
Z-2251-2024Class IBAUSCH+LOMB, I-PACK Injection Kit, REF 18060, for the administration of intravitreal injection (eye)June 12, 2024
Z-2252-2024Class IBAUSCH+LOMB, I-PACK Injection Kit with Drape, REF 18061, for the administration of intravitreal injeJune 12, 2024
Z-0119-2017Class II25 gauge VersaVit 2.0 Core Essentials Procedure Pack, Product/Part Number 70025E, packaged in HIPS rAugust 11, 2016
Z-0122-2017Class II25 gauge VersaVit 2.0 Vitrectomy Cutter, Product/Part Number 70935, packaged in a Tyvek/Mylar doubleAugust 11, 2016
Z-0120-2017Class II25 gauge VersaVit 2.0 Procedure Pack with Mid-Field Illuminator, Product/Part Number 70025S, packageAugust 11, 2016
Z-0121-2017Class II25 gauge VersaVit 2.0 Procedure Pack with Photon Wide Field Illuminator, Product/Part Number 70025SPAugust 11, 2016
Z-0887-2014Class II27ga ONE-STEP (tm) Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO, 56.02.27P. PacDecember 9, 2013
Z-0876-2014Class II23ga Chandelier Infusion Cannula, Synergetics, inc., length 8.0 ft, sterile / EO, 56.30.23P. Packed December 9, 2013
Z-0879-2014Class II25ga Awh Chandelier, Synergetics, inc., B&L Cannula Compatible, length 8.0 ft, sterile / EO, 56.52.2December 9, 2013
Z-0894-2014Class II23ga Wide Field Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO, 56.21.23P. Packed December 9, 2013
Z-0889-2014Class II23ga Wide Field Corona Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO, 56.12.23P. December 9, 2013
Z-0893-2014Class IIWide Field Endo Illuminator, Vivid (tm) Endo Illuminator, 20ga, Synergetics, inc., 20ga, length 7.5 December 9, 2013
Z-0881-2014Class II27ga ONE-STEP (tm) Awh/Tano Vivid Chandelier, Synergetics, length 8.0 ft, sterile / EO, 56.55.27P. PDecember 9, 2013
Z-0882-2014Class II23ga Straight Fixed Extended Illuminated Laser Probe, Synergetics, length 7.5 ft, sterile / EO, 55.6December 9, 2013
Z-0873-2014Class II23ga Chow Illuminated Pick, Synergetics, inc., length 7.5 ft, sterile / EO, 56.07.23P. Packed 12 uniDecember 9, 2013
Z-0884-2014Class II23ga Endo Illuminator (Eckardt Trocar Compatible), Synergetics, inc., length 8.0 ft, sterile / EO, 5December 9, 2013
Z-0895-2014Class IIStiff 25ga Wide Field Endo Illuminator, Synergetics, inc. length 7.5 ft, sterile / EO, 56.21.25PS. PDecember 9, 2013
Z-0896-2014Class II23ga Mid-Field Endo Illuminator, Synergetics length 7.5 ft, sterile / EO, 56.22.23P. Packed 12 unitsDecember 9, 2013

Recent 510(k) Clearances

K-NumberDeviceDate
K160103Spetzler Malis Dual Illuminating Bipolar ForcepsOctober 12, 2016
K143123Synergetics PHOTON EXFebruary 24, 2015
K121426AYNERGETICS DISPOSABLE SPETZLER-MALIS STANDARD BIPOLAR FORCEPSJuly 10, 2012
K121675VERSAVITJune 21, 2012
K113857SYNERGETICS DIRECTIONAL ENDOOCULAR LASER PROBEApril 23, 2012
K110924DISPOSABLE SPETZLER-MALIS DUAL IRRIGATING BIPOLAR FORCEPSDecember 7, 2011
K091441SYNERGETICS ADJUSTABLE GAS PRESSURIZED INFUSION (AGPI) TUBE SETOctober 30, 2009
K071482STRYKER RF MULTI-LESION GENERATOR, MODEL 0406-900-000December 20, 2007
K063489STRYKER INTRADISCAL RF GENERATORMay 23, 2007
K032598SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCENovember 24, 2003
K020220ULTRASONIC STRAIGHT/ULTRASONIC KNIFE/ULTRASONIC RING CURRETTEAugust 23, 2002
K010637SONOTOME ULTRASONIC ASPIRATOR TIPSApril 20, 2001
K990568SCRAMBLED ENDOOTO LASER PROBE, STRAIGHT TIP, MODEL 59.02, SCRAMBLED ENDOOTO LASER PROBE BENT TIP, MOMay 14, 1999
K982212VERITAS BIPOLAR, INSULATED, 0.5MM TIP, MODEL N301-005 VERITAS BIPOLAR, INSULATED 1.0MM TIP MODEL N30December 2, 1998
K964005SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCEJune 9, 1997
K932668OPHTHALMIC SURGICAL PNEUMATIC SCISSORS DRIVERFebruary 23, 1994
K923725OPHTHALMIC PHARCO NEEDLEMarch 18, 1993
K923326OPHTHALMIC VISCOINJECTOR DRIVESeptember 30, 1992

FDA data resources