510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K952008Substantially Equivalent

Karl Storz Drill

Karl Storz Endoscopy-America, Inc., Culver City CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K952008 is the FDA 510(k) clearance record for KARL STORZ DRILL, a class I device, cleared for KARL STORZ Endoscopy-America, Inc. on under FDA product code GEY (Motor, Surgical Instrument, Ac-Powered). FDA records list 402 510(k) clearances for KARL STORZ Endoscopy-America, Inc., from to . As of , FDA records show no recalls naming K952008.

Clearance record

Decision date
Received
(89 days to decision)
Product code
GEY Motor, Surgical Instrument, Ac-Powered
Regulation
21 CFR 878.4820
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
KARL STORZ Endoscopy-America, Inc. 600 Corporate Pt.e, Culver City CA
510(k) summary
Summary
Third party review
No

Clearances, product code GEY

Trailing 12 months

FDA records hold no clearances under product code GEY in the trailing twelve months.

FDA records show no clearances under product code GEY in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GEY, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260