510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K150468Substantially Equivalent

Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs

K2 Medical GmbH & Co. KG, Tuttlingen, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K150468 is the FDA 510(k) clearance record for Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs, a class II device, cleared for K2 Medical GmbH & Co. KG on under FDA product code HAE (Rongeur, Manual). FDA records list 2 510(k) clearances for K2 Medical GmbH & Co. KG, from to . As of , FDA records show no recalls naming K150468.

Clearance record

Decision date
Received
(371 days to decision)
Product code
HAE Rongeur, Manual
Regulation
21 CFR 882.4840
Device class
Class II
Review panel
Neurology
Applicant
K2 Medical GmbH & Co. KG Unter Buchsteig 5, Tuttlingen, DE
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