510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K110121Substantially Equivalent

Wexler Endoscope Accessories

Microsurgical Laboratories,Inc.Dba Wexler Surgical, Bellaire TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K110121 is the FDA 510(k) clearance record for WEXLER ENDOSCOPE ACCESSORIES, a class II device, cleared for Microsurgical Laboratories,Inc.Dba Wexler Surgical 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 3 510(k) clearances for Microsurgical Laboratories,Inc.Dba Wexler Surgical, from to . As of , FDA records show no recalls naming K110121.

Clearance record

Decision date
Received
(112 days to decision)
Product code
GCJ Laparoscope, General & Plastic Surgery
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Microsurgical Laboratories,Inc.Dba Wexler Surgical 540 College St., Bellaire TX
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