510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K923964Substantially Equivalent

Nk Grasp Sensor, Model Ga001

Nk Biotechnical Engineering Co., Minneapolis MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K923964 is the FDA 510(k) clearance record for NK GRASP SENSOR, MODEL GA001, a class II device, cleared for Nk Biotechnical Engineering Co. on under FDA product code LBB (Dynamometer, Ac-Powered). FDA records list 15 510(k) clearances for Nk Biotechnical Engineering Co., from to . As of , FDA records show no recalls naming K923964.

Clearance record

Decision date
Received
(278 days to decision)
Product code
LBB Dynamometer, Ac-Powered
Regulation
21 CFR 888.1240
Device class
Class II
Review panel
Orthopedic
Applicant
Nk Biotechnical Engineering Co. P.O. Box 26335, Minneapolis MN
510(k) summary
Statement
Third party review
No

Clearances, product code LBB

Trailing 12 months

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

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