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510(k) K022246

MODIFICATION TO SYMPHONY GRAFT DELIVERY SYSTEM by Depuyacromed — Product Code FMF

K022246 is an FDA 510(k) premarket notification submitted by Depuyacromed for the device "MODIFICATION TO SYMPHONY GRAFT DELIVERY SYSTEM". The FDA issued a decision of Substantially Equivalent on August 2, 2002. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Depuyacromed has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 2002
Date Received
July 12, 2002
Clearance Type
Special
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 Depuyacromed

  • K040197 — EAGLE ANTERIOR CERVIAL PLATE SYSTEM (April 2, 2004)
  • K031635 — DEPUY ACROMED VBR SYSTEM (June 23, 2003)
  • K030833 — DEPUY ACROMED VBR SYSTEM (April 10, 2003)
  • K030383 — MODIFICATION TO MOSS MIAMI SPINAL SYSTEM POLYAXIAL SCREWS (February 26, 2003)
  • K030249 — SURGICAL TITANIUM MESH SYSTEM (February 14, 2003)
  • K030103 — SUMMIT OCT SPINAL SYSTEM MINIPOLYAXIAL SCREWS (February 5, 2003)
  • K023835 — DEVEX MESH SYSTEM (January 29, 2003)
  • K024348 — MONARCH SPINE SYSTEM (January 28, 2003)
  • K023804 — MOSS MIAMI SPINAL SYSTEM PIN NUT (January 23, 2003)
  • K021039 — BOWTI ANTERIOR BUTTRESS STAPLE SYSTEM (December 11, 2002)

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