510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K945978Substantially Equivalent

Tubing, Noninvasive

Endoscopic Technologies, Inc., Norcross GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K945978 is the FDA 510(k) clearance record for TUBING, NONINVASIVE, a class II device, cleared for Endoscopic Technologies, Inc. on under FDA product code GAZ (Tubing, Noninvasive). FDA records list 8 510(k) clearances for Endoscopic Technologies, Inc., from to . As of , FDA records show no recalls naming K945978.

Clearance record

Decision date
Received
(34 days to decision)
Product code
GAZ Tubing, Noninvasive
Regulation
21 CFR 880.6740
Device class
Class II
Review panel
General Hospital
Applicant
Endoscopic Technologies, Inc. 6550a Best Friend Rd., Norcross GA
510(k) summary
Statement
Third party review
No

Clearances, product code GAZ

Trailing 12 months

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

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