510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K171947Substantially Equivalent

Soloassist II

AKTORmed GmbH, Barbing, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K171947 is the FDA 510(k) clearance record for SOLOASSIST II, a class II device, cleared for Aktormed GmbH on under FDA product code NAY (System, Surgical, Computer Controlled Instrument). FDA's definition for product code NAY reads: "If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at...". FDA records list 5 510(k) clearances for Aktormed GmbH, from to . As of , FDA records show no recalls naming K171947.

Clearance record

Decision date
Received
(449 days to decision)
Product code
NAY System, Surgical, Computer Controlled Instrument
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Aktormed GmbH Borsigstrabe 13, Barbing, DE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NAY

Trailing 12 months
9 clearances under product code NAY in the twelve months to October 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code NAY, trailing twelve months
MonthClearances
November 20250
December 20252
January 20262
February 20260
March 20261
April 20260
May 20262
June 20260
July 20261
August 20260
September 20261
October 20260