510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K982965Substantially Equivalent

Endocam Camera Systems 5502/5507 with Cr Camera Heads and Accessories

Richard Wolf Medical Instruments Corp., Vernon Hills IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K982965 is the FDA 510(k) clearance record for ENDOCAM CAMERA SYSTEMS 5502/5507 WITH CR CAMERA HEADS AND ACCESSORIES, a class I device, cleared for Richard Wolf Medical Instruments Corp. on under FDA product code FWF (Camera, Television, Endoscopic, Without Audio). FDA records list 153 510(k) clearances for Richard Wolf Medical Instruments Corp., from to . As of , FDA records show no recalls naming K982965.

Clearance record

Decision date
Received
(90 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
Richard Wolf Medical Instruments Corp. 353 Corporate Woods Pkwy., Vernon Hills IL
510(k) summary
Summary
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