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510(k) K150156

Ranfac Fat Aspiration Transfer Syringe (FATS) Procedure Pack, Ranfac Fat Aspiration Transfer Syringe (FATS) Containment Vessel by Ranfac, Corp. — Product Code MUU

K150156 is an FDA 510(k) premarket notification submitted by Ranfac, Corp. for the device "Ranfac Fat Aspiration Transfer Syringe (FATS) Procedure Pack, Ranfac Fat Aspiration Transfer Syringe (FATS) Containment Vessel". The FDA issued a decision of Substantially Equivalent on October 19, 2015. The device falls under product code MUU (System, Suction, Lipoplasty), a Class II device regulated under 21 CFR 878.5040. Ranfac, Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 2015
Date Received
January 23, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Suction, Lipoplasty
Device Class
Class II
Regulation Number
878.5040
Review Panel
SU
Submission Type

See Federal Register Notice at 86 FR 50887 “Consolidation of Devices That Process Autologous Human Cells, Tissues, and Cellular and Tissue-Based Products at the Point of Care to Produce a Therapeutic Article” (FRN) (FDA-2021-N-0881).

Other clearances by Ranfac, Corp.

  • K162932 — Ranfac Fat Aspiration Cannula (January 19, 2017)
  • K150563 — Marrow Cellution Bone Marrow Aspiration Needle (May 22, 2015)
  • K140991 — RANFAC ASPIRATION NEEDLE WITH ADJUSTABLE GUIDE (September 11, 2014)
  • K131157 — RANFAC BONE MARROW ASPIRATION NEEDLE (October 22, 2013)
  • K031344 — RANFAC GOLDENBERG SNARECOIL SOFT TISSUE BIOPSY (GSS) NEEDLE (May 23, 2003)
  • K012224 — SINGLE ACTION BIOPSY NEEDLE, MODEL RCBS: XX GAUGE, XX LENGTH, XX THROW (August 22, 2001)
  • K961922 — RDP-2 (August 9, 1996)
  • K951090 — INTRODUCER (July 11, 1995)
  • K930474 — NEEDLE, PNEUMOPERITONEUM, SPRING LOADED (July 23, 1993)
  • K864139 — RANFAC CUT BIOPSY NEEDLE (November 5, 1986)

Other clearances for product code MUU

  • K210528 — IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit, IntelliFat Bod (March 16, 2022)
  • K203800 — SyntrFuge System (July 2, 2021)
  • K202443 — Smart Kit Basic, Smart Kit Pro (March 11, 2021)
  • K193539 — REVOLVE ENVI 600 Advanced Adipose System (May 28, 2020)
  • K193363 — Dermapose Refresh (April 14, 2020)
  • K182732 — JTL-250-01 (November 18, 2019)
  • K191564 — Progenikine Concentrating System 25 mL System (November 7, 2019)
  • K190386 — KTA Adipose Treatment Kit (October 10, 2019)
  • K190278 — AuraGen 123 Suction Lipoplasty System (A123) (May 3, 2019)
  • K172717 — Automatic Tissue Processing Unit (May 25, 2018)

FDA data resources