510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K161507Substantially Equivalent

Cianna Medical SAVI Scout Reflector and SAVI Scout System

Cianna Medical, Inc., Aliso Viejo CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K161507 is the FDA 510(k) clearance record for Cianna Medical SAVI Scout Reflector and SAVI Scout System, a class II device, cleared for Cianna Medical, Inc. on under FDA product code PDW (Internal Tissue Marker). FDA's definition for product code PDW reads: "An internal tissue marker is a prescription use device that is intended for use prior to or during general surgical procedures to demarcate selected sites on internal tissues". FDA records list 10 510(k) clearances for Cianna Medical, Inc., from to . As of , FDA records show no recalls naming K161507.

Clearance record

Decision date
Received
(58 days to decision)
Product code
PDW Internal Tissue Marker
Regulation
21 CFR 878.4670
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Cianna Medical, Inc. 6 Journey, Suite 125, Aliso Viejo CA
510(k) summary
Statement
Third party review
No

Clearances, product code PDW

Trailing 12 months

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

FDA records show no clearances under product code PDW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PDW, 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