510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K193346Substantially Equivalent

Codman Surgical Patties & Strips

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

K193346 is the FDA 510(k) clearance record for Codman Surgical Patties & Strips, a class II device, cleared for Integra LifeSciences Corporation on under FDA product code HBA (Neurosurgical Paddie). FDA records list 94 510(k) clearances for Integra LifeSciences Corporation, from to . As of , FDA records show 23 recalls naming K193346.

Clearance record

Decision date
Received
(353 days to decision)
Product code
HBA Neurosurgical Paddie
Regulation
21 CFR 882.4700
Device class
Class II
Review panel
Neurology
Applicant
Integra LifeSciences Corporation 11 Cabot Blvd., Mansfield MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HBA

Trailing 12 months

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

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