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NAV PAK Needle, NIM NAV PAK Needle

by Boston Endo Surgical Tech, 510(k)

Active United States

510(k) K182662

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK182662 Date10 Apr 2019ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 11 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
PDQ
Device Class
Class II
Regulation
21 CFR Part 874.1820
Advisory Committee
Ear, Nose, Throat
FDA Decision
SESE Substantially Equivalent

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