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KARL STORZ NAV1 Electromagnetic Navigation System

by Karl Storz Endoscopy-America, Inc. 510(k)

Active United States

510(k) K161555

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK161555 Date21 Oct 2016ClearedStatusActive

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  • Withdrawn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 8 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
PGW
FDA applicant
Karl Storz Endoscopy America, Inc.
Device Class
Class II
Regulation
21 CFR Part 882.4560
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

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