510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K963642Substantially Equivalent

Incl II Endoscope

Sofamor Danek USA,Inc., Memphis TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K963642 is the FDA 510(k) clearance record for INCL II ENDOSCOPE, a class II device, cleared for Sofamor Danek USA,Inc. on under FDA product code GWG (Endoscope, Neurological). FDA's definition for product code GWG reads: "If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at...". FDA records list 42 510(k) clearances for Sofamor Danek USA,Inc., from to . As of , FDA records show no recalls naming K963642.

Clearance record

Decision date
Received
(552 days to decision)
Product code
GWG Endoscope, Neurological
Regulation
21 CFR 882.1480
Device class
Class II
Review panel
Neurology
Applicant
Sofamor Danek USA,Inc. 1800 Pyramid Pl., Memphis TN
510(k) summary
Summary
Third party review
No

Clearances, product code GWG

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