510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K881014Substantially Equivalent

The Karl Storz Mini 9000 Solid State Ccd Video Cam

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

K881014 is the FDA 510(k) clearance record for THE KARL STORZ MINI 9000 SOLID STATE CCD VIDEO CAM, a class I device, cleared for KARL STORZ Endoscopy-America, Inc. on under FDA product code FWF (Camera, Television, Endoscopic, Without Audio). FDA records list 402 510(k) clearances for KARL STORZ Endoscopy-America, Inc., from to . As of , FDA records show no recalls naming K881014.

Clearance record

Decision date
Received
(35 days to decision)
Product code
FWF Camera, Television, Endoscopic, Without Audio
Regulation
21 CFR 878.4160
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
KARL STORZ Endoscopy-America, Inc. 10111 W. Jefferson Blvd., Culver City CA
Third party review
No

Clearances, product code FWF

Trailing 12 months

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

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