510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K163654Substantially Equivalent

VersaOne fascial closure system bladed trocar, VersaOne fascial closure system bladeless trocar, VersaOne fascial closure system optical trocar

Medtronic, Inc., North Haven CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K163654 is the FDA 510(k) clearance record for VersaOne fascial closure system bladed trocar, VersaOne fascial closure system bladeless trocar, VersaOne fascial closure system optical trocar, a class II device, cleared for Covidien, LLC on under FDA product code GCJ (Laparoscope, General & Plastic Surgery). FDA's definition for product code GCJ reads: "Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available...". FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show no recalls naming K163654.

Clearance record

Decision date
Received
(75 days to decision)
Product code
GCJ Laparoscope, General & Plastic Surgery
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Covidien, LLC 60 Middletown Ave., North Haven CT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GCJ

Trailing 12 months
27 clearances under product code GCJ in the twelve months to October 2026, February 2026 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code GCJ, trailing twelve months
MonthClearances
November 20252
December 20250
January 20263
February 20264
March 20260
April 20263
May 20264
June 20264
July 20263
August 20262
September 20262
October 20260