510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K070426Substantially Equivalent

Silhouette, Model 1000.01

Aranz Medical Limited, Christchurch, Canterbury, NZ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K070426 is the FDA 510(k) clearance record for SILHOUETTE, MODEL 1000.01, a class I device, cleared for Aranz Medical Limited on under FDA product code FXN (Tape, Camera, Surgical). FDA records list one 510(k) clearance for Aranz Medical Limited. As of , FDA records show no recalls naming K070426.

Clearance record

Decision date
Received
(136 days to decision)
Product code
FXN Tape, Camera, Surgical
Regulation
21 CFR 878.4160
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Aranz Medical Limited Ground Floor St. Elmo Ct.s, Christchurch, Canterbury, NZ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FXN

Trailing 12 months

FDA records hold no clearances under product code FXN in the trailing twelve months.

FDA records show no clearances under product code FXN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FXN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260