510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K092227Substantially Equivalent

Jarit, Ruggles, R&b Redmond/ Redmond, Miltex, Meisterhand - Kerrison Rongeurs

Integra LifeSciences Corporation, York PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K092227 is the FDA 510(k) clearance record for JARIT, RUGGLES, R&B REDMOND/ REDMOND, MILTEX, MEISTERHAND - KERRISON RONGEURS, a class II device, cleared for Integra Lifesciences Corp. on under FDA product code HAE (Rongeur, Manual). FDA records list 94 510(k) clearances for Integra Lifesciences Corp., from to . As of , FDA records show no recalls naming K092227.

Clearance record

Decision date
Received
(209 days to decision)
Product code
HAE Rongeur, Manual
Regulation
21 CFR 882.4840
Device class
Class II
Review panel
Neurology
Applicant
Integra Lifesciences Corp. 589 Davies Dr., York PA
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 November 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HAE, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260
November 20260