510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K891187Substantially Equivalent

Tecnol Naso-Gastric Tube Holder

Tecnol New Jersey Wound Care, Inc., Fort Worth TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K891187 is the FDA 510(k) clearance record for TECNOL NASO-GASTRIC TUBE HOLDER, a class II device, cleared for Tecnol New Jersey Wound Care, Inc. on under FDA product code BSS (Tube, Nasogastric). FDA records list 35 510(k) clearances for Tecnol New Jersey Wound Care, Inc., from to . As of , FDA records show no recalls naming K891187.

Clearance record

Decision date
Received
(85 days to decision)
Product code
BSS Tube, Nasogastric
Regulation
21 CFR 876.5980
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Tecnol New Jersey Wound Care, Inc. 7201 Industrial Park Blvd., Fort Worth TX
Third party review
No

Clearances, product code BSS

Trailing 12 months

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

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