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
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K132015Substantially Equivalent

Truclear Morcellation System and Truclear Morcellators

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

K132015 is the FDA 510(k) clearance record for TRUCLEAR MORCELLATION SYSTEM AND TRUCLEAR MORCELLATORS, a class II device, cleared for Smith & Nephew, Inc. on under FDA product code HIH (Hysteroscope (And Accessories)). FDA records list 572 510(k) clearances for Smith & Nephew, Inc., from to . As of , FDA records show one recall naming K132015.

Clearance record

Decision date
Received
(165 days to decision)
Product code
HIH Hysteroscope (And Accessories)
Regulation
21 CFR 884.1690
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Smith & Nephew, Inc. 150 Minuteman Rd., Andover MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HIH

Trailing 12 months
8 clearances under product code HIH in the twelve months to October 2026, September 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code HIH, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20261
March 20260
April 20260
May 20261
June 20261
July 20260
August 20261
September 20263
October 20260