510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K070715Substantially Equivalent

Nasopore Ear

Polyganics B.V., Groningen, NL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K070715 is the FDA 510(k) clearance record for NASOPORE EAR, a class II device, cleared for Polyganics B.V., on under FDA product code NHB (Polymer, Ear, Nose And Throat, Synthetic, Absorbable). FDA's definition for product code NHB reads: "Ear, nose, and throat absorbable synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is shaped and formed by...". FDA records list 9 510(k) clearances for Polyganics B.V.,, from to . As of , FDA records show 13 recalls naming K070715.

Clearance record

Decision date
Received
(54 days to decision)
Product code
NHB Polymer, Ear, Nose And Throat, Synthetic, Absorbable
Regulation
21 CFR 874.3620
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Polyganics B.V., L.J. Zielstraweg 1, Groningen, NL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NHB

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