510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K081651Substantially Equivalent

Instrumed Rongeur

Instrumed International Inc dba Avalign German Specialty Instruments, Schaumburg IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K081651 is the FDA 510(k) clearance record for INSTRUMED RONGEUR, a class II device, cleared for Instrumed International, Inc. on under FDA product code HAE (Rongeur, Manual). FDA records list 7 510(k) clearances for Instrumed International Inc dba Avalign German Specialty Instruments, from to . As of , FDA records show no recalls naming K081651.

Clearance record

Decision date
Received
(57 days to decision)
Product code
HAE Rongeur, Manual
Regulation
21 CFR 882.4840
Device class
Class II
Review panel
Neurology
Applicant
Instrumed International, Inc. 626 Cooper Ct., Schaumburg IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HAE

Trailing 12 months
1 clearance under product code HAE 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 HAE, 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