Alignment Instrument

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K970345 ↗

FDA Product Code

HSZ

Device Class

Class I

Regulation

21 CFR Part 878.4820

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Suction and Irrigation Tubes

  Class II

  FDA 510(k) K940960 Active Cleared 8 Nov 1994

• Needle, Spray

  Class II

  FDA 510(k) K770710 Active Cleared 26 Apr 1977

• Trocars Trotec with Automatic Protective Mechanism

  Class II

  FDA 510(k) K003164 Active Cleared 8 Jan 2001

• Resection Pump, Resectoscope for Chip Aspiration, Endoscope 25/ 3.3 Mm, Accessories

  Class II

  FDA 510(k) K042523 Active Cleared 18 Mar 2005

• Endoscopes W/Permanent and Removable Eyepiece, Panoview Plus Telescope W/Plug-on Connector

  Class II

  FDA 510(k) K972927 Active Cleared 6 Nov 1997

• Flexible Video Cystoscope/Choledochoscope, Models 7308.061 and 7308.066

  Class II

  FDA 510(k) K051176 Active Cleared 5 Oct 2005

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