510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K132264Substantially Equivalent

Primado2 Total Surgical System

Nakanishi Inc., Richardson TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K132264 is the FDA 510(k) clearance record for PRIMADO2 TOTAL SURGICAL SYSTEM, a class II device, cleared for Nakanishi, Inc. on under FDA product code HBC (Motor, Drill, Electric). FDA records list 40 510(k) clearances for Nakanishi, Inc., from to . As of , FDA records show no recalls naming K132264.

Clearance record

Decision date
Received
(148 days to decision)
Product code
HBC Motor, Drill, Electric
Regulation
21 CFR 882.4360
Device class
Class II
Review panel
Neurology
Applicant
Nakanishi, Inc. 1201 Richardson Dr., Suite 280, Richardson TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HBC

Trailing 12 months
1 clearance under product code HBC in the twelve months to October 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HBC, 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 20261
October 20260