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510(k) K230715

Promisemed Safety Huber Needle by Promisemed Hangzhou Meditech Co., Ltd. — Product Code PTI

K230715 is an FDA 510(k) premarket notification submitted by Promisemed Hangzhou Meditech Co., Ltd. for the device "Promisemed Safety Huber Needle". The FDA issued a decision of Substantially Equivalent on June 8, 2023. The device falls under product code PTI (Non-Coring (Huber) Needle), a Class II device regulated under 21 CFR 880.5570. Promisemed Hangzhou Meditech Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 8, 2023
Date Received
March 15, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Non-Coring (Huber) Needle
Device Class
Class II
Regulation Number
880.5570
Review Panel
HO
Submission Type

The non-coring needle (Huber) is utilized to gain access into a subcutaneous implanted intravascular infusion port but can also be used to access other non-vascular implanted devices with similar septums.

Other clearances by Promisemed Hangzhou Meditech Co., Ltd.

  • K261196 — Promisemed VeriEcto Automatic Biopsy Needles (May 12, 2026)
  • K261045 — Verifine Safety Lancets (May 1, 2026)
  • K254273 — Verisafe Safety Sterile Needles (SSN) (April 16, 2026)
  • K250192 — Verisafe Safety Retractable Insulin Syringes (December 10, 2025)
  • K250961 — Blood collection tube holders (June 4, 2025)
  • K251138 — Promisemed Safety Huber Needles (May 13, 2025)
  • K243332 — Promisemed Safety Huber Needles (March 14, 2025)
  • K243806 — Safety Winged Blood Collection Sets (January 10, 2025)
  • K240675 — Endoscopic Injection Needles (October 4, 2024)
  • K242632 — Verifine® Pen Needles (September 26, 2024)

Other clearances for product code PTI

  • K252355 — K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing (November 26, 2025)
  • K251138 — Promisemed Safety Huber Needles (May 13, 2025)
  • K243332 — Promisemed Safety Huber Needles (March 14, 2025)
  • K241353 — PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle Set (November 27, 2024)
  • K213823 — Intera Refill Kit (March 16, 2022)
  • K211121 — Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolu (October 14, 2021)
  • K200463 — Huber Needle Infusion Set, Safety Huber Needle Infusion Set (April 7, 2021)
  • K170881 — ISP Safety Huber Needle Infusion Set (December 14, 2017)
  • K170897 — Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle wit (November 3, 2017)
  • K171735 — PowerLoc MAX Power-Injectable Infusion Set and SafeStep Huber Needle Set (August 8, 2017)

FDA data resources