510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K103215Substantially Equivalent

Cianna S1, Single Lumen Balloon Applicator Kit

Cianna Medical, Inc., Aliso Viejo CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K103215 is the FDA 510(k) clearance record for CIANNA S1, SINGLE LUMEN BALLOON APPLICATOR KIT, a class II device, cleared for Cianna Medical on under FDA product code JAQ (System, Applicator, Radionuclide, Remote-Controlled). FDA records list 10 510(k) clearances for Cianna Medical, from to . As of , FDA records show no recalls naming K103215.

Clearance record

Decision date
Received
(14 days to decision)
Product code
JAQ System, Applicator, Radionuclide, Remote-Controlled
Regulation
21 CFR 892.5700
Device class
Class II
Review panel
Radiology
Applicant
Cianna Medical 6 Journey, Suite 125, Aliso Viejo CA
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code JAQ

Trailing 12 months
4 clearances under product code JAQ in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JAQ, trailing twelve months
MonthClearances
November 20251
December 20251
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20261
August 20260
September 20260
October 20260