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510(k) K000456

HARVEST TECHNOLOGIES DUAL LIQUID APPLICATOR, MODEL SK/S: HARVEST DUAL LIQUID APPLICATOR LK/2 by Harvest Technologies, LLC — Product Code FMF

K000456 is an FDA 510(k) premarket notification submitted by Harvest Technologies, LLC for the device "HARVEST TECHNOLOGIES DUAL LIQUID APPLICATOR, MODEL SK/S: HARVEST DUAL LIQUID APPLICATOR LK/2". The FDA issued a decision of Substantially Equivalent on June 1, 2000. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Harvest Technologies, LLC has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 1, 2000
Date Received
February 11, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Piston
Device Class
Class II
Regulation Number
880.5860
Review Panel
HO
Submission Type

Other clearances by Harvest Technologies, LLC

  • K121005 — ADIPREP ADIPOSE TRANSFER SYSTEM (September 21, 2012)
  • K103340 — SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM (December 6, 2010)
  • K052925 — SMARTPREP2 CENTRIFUGE SYSTEM (January 4, 2006)
  • K043261 — HARVEST GRAFT DELIVERY SYRINGE (March 11, 2005)
  • K020252 — SMARTJET GRAFTING LIQUID APPLICATOR, MODELS SK/S & LK/2 (April 5, 2002)
  • K011032 — SMARTJET BONE GRAFT LIQUID APPLICATOR (SPRAY TIP), MODEL SK/S, SMARTJET BONE GRA (July 3, 2001)
  • K991430 — SMARTPREP CENTRIFUGE SYSTEM (May 28, 1999)
  • K983022 — SMARTCELL PROCESSING SYSTEM (April 2, 1999)

Other clearances for product code FMF

  • K260208 — Ultra-Fine™ SAFETY Insulin Syringe (July 13, 2026)
  • K253110 — Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe (June 18, 2026)
  • K260514 — Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low (June 12, 2026)
  • K253112 — Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); (May 21, 2026)
  • K252279 — Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml) (April 17, 2026)
  • K253068 — Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin Syringe (February 23, 2026)
  • K253769 — Instylla Delivery Kit (December 22, 2025)
  • K252518 — DuoprossTM Smart Cap (Type I) (December 17, 2025)
  • K251089 — EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Sy (December 12, 2025)
  • K250192 — Verisafe Safety Retractable Insulin Syringes (December 10, 2025)

FDA data resources