510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K971338Substantially Equivalent

Syntec, Inc. Disposable Bare End Fiber

Syntec, Inc., Crystal City MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K971338 is the FDA 510(k) clearance record for SYNTEC, INC. DISPOSABLE BARE END FIBER, a class II device, cleared for Syntec, Inc. on under FDA product code MPA (Endoilluminator). FDA records list 3 510(k) clearances for Syntec, Inc., from to . As of , FDA records show no recalls naming K971338.

Clearance record

Decision date
Received
(26 days to decision)
Product code
MPA Endoilluminator
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Syntec, Inc. 812 Truman Blvd., Crystal City MO
510(k) summary
Summary
Third party review
No

Clearances, product code MPA

Trailing 12 months
1 clearance under product code MPA in the twelve months to October 2026, August 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MPA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260