1070/15 to 1078/17 Various Types Needle Holders

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K851719 ↗

FDA Product Code

EZZ

Device Class

Class III

Advisory Committee

Unknown

FDA Decision

SESE Substantially Equivalent

• 7-120, 7-130, 7-140, 7-150, 9-151 to 168, 9-171 to 1

  Class I

  FDA 510(k) K851751 Active Cleared 20 Jun 1985

• 13-270 Kilner Scissors

  Not classified

  FDA 510(k) K851760 Active Cleared 20 Jun 1985

• 600/203 to 650/74XN Various Types of Dent Extracti

  Class I

  FDA 510(k) K851712 Active Cleared 11 Jun 1985

• 19-790 to 19-1042 Dressing/Sponge Forceps

  Class I

  FDA 510(k) K851775 Active Cleared 11 Jun 1985

• 13-320, 13-330 Two Types Nazal Scissors-Heyman, Beck

  Class I

  FDA 510(k) K851763 Active Cleared 11 Jun 1985

• 15-490 to 15-520 Various Splinter Forceps Peet, St

  Class I

  FDA 510(k) K851771 Active Cleared 20 Jun 1985

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• What types of surgical procedures are these needle holders specifically designed for, and why are they considered essential in those contexts?

  These needle holders (1070/15 to 1078/17) are designed for precise manipulation of needles during reconstructive or obstructive urological interventions involving the vas deferens. They provide stability and control for delicate tissue handling, ensuring accurate needle placement and suturing—critical for procedures like vasectomy reversals or vas deferens anastomosis where precision minimizes trauma and improves outcomes.

• Are these needle holders single-use or reusable, and what maintenance is required to keep them safe for repeated use?

  These needle holders are reusable and must be sterilized between uses to maintain safety and functionality. Proper sterilization and maintenance are essential, as they are intended for sterile environments like operating rooms. The manufacturer emphasizes adherence to sterilization protocols to ensure they remain effective for subsequent procedures.

• How do I determine which size (e.g., 1070/15 to 1078/17) is best for my surgical needs, and does the size affect performance?

  The needle holders come in multiple sizes (1070/15 through 1078/17), each likely designed for specific needle gauges or procedural requirements. Smaller sizes (e.g., 1070/15) may offer finer control for delicate tissues, while larger sizes (e.g., 1078/17) could provide better grip for thicker needles. The choice depends on the needle type and surgical technique—consulting product documentation or a surgical specialist can help match the right size to your procedure for optimal precision.

• How were these needle holders determined to be substantially equivalent to predicate devices, and what does that mean for their use in clinical settings?

  The FDA classified these needle holders as substantially equivalent (SESE) to a predicate device through a traditional 510(k) review (K851719), meaning they have the same intended use and technological characteristics as the prior-approved product. Clinically, this means they meet established safety and effectiveness standards for holding and securing needles in vas deferens procedures, allowing surgeons to rely on them with confidence in sterile environments like operating rooms.