510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K102544Substantially Equivalent

Smith & Nephew Hip Arthroscopy Repair Instrument Tray

Smith & Nephew, Inc., Mansfield MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K102544 is the FDA 510(k) clearance record for SMITH & NEPHEW HIP ARTHROSCOPY REPAIR INSTRUMENT TRAY, a class II device, cleared for Smith & Nephew Inc., Endoscopy Div. on under FDA product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories). FDA records list 572 510(k) clearances for SMITH & NEPHEW INC., from to . As of , FDA records show one recall naming K102544.

Clearance record

Decision date
Received
(124 days to decision)
Product code
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Regulation
21 CFR 880.6850
Device class
Class II
Review panel
General Hospital
Applicant
Smith & Nephew Inc., Endoscopy Div. 130 Forbes Blvd., Mansfield MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KCT

Trailing 12 months
8 clearances under product code KCT in the twelve months to October 2026, June 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code KCT, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20262
March 20260
April 20260
May 20260
June 20263
July 20260
August 20260
September 20262
October 20260