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Ksea Model 383320 20 Angiomat

by Karl Storz Endoscopy 510(k)

Active United States

510(k) K960486

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK960486 Date25 Oct 1996ClearedStatusActive

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  • Withdrawn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
DQI
Device Class
Class II
Regulation
21 CFR Part 870.1800
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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