510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K173335Substantially Equivalent

Gazelle PTFE and Suture Delivery Device

Dura Tap, LLC, Wayne PA / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K173335 is the FDA 510(k) clearance record for Gazelle PTFE and Suture Delivery Device, a class II device, cleared for Dura Tap, LLC on under FDA product code NBY (Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene). FDA records list 2 510(k) clearances for Dura Tap, LLC, from to . As of , FDA records show no recalls naming K173335.

Clearance record

Decision date
Received
(108 days to decision)
Product code
NBY Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
Regulation
21 CFR 878.5035
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Dura Tap, LLC 208 Upland Way, Wayne PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NBY

Trailing 12 months

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

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