510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K113080Substantially Equivalent

Tubalgator

Mectra Labs, Inc., Bloomfield IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K113080 is the FDA 510(k) clearance record for TUBALGATOR, a class II device, cleared for Mectra Labs, Inc. on under FDA product code HIN (Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)). FDA records list 9 510(k) clearances for Mectra Labs, Inc., from to . As of , FDA records show no recalls naming K113080.

Clearance record

Decision date
Received
(255 days to decision)
Product code
HIN Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)
Regulation
21 CFR 884.4150
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Mectra Labs, Inc. Two Quality Way, Bloomfield IN
510(k) summary
Statement
Third party review
No

Clearances, product code HIN

Trailing 12 months

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

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