510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K053412Substantially Equivalent

Flexiscope, Models 50Mh and 50 Mhc

Schoelly Imaging, Inc., Ayer MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K053412 is the FDA 510(k) clearance record for FLEXISCOPE, MODELS 50MH AND 50 MHC, a class I device, cleared for Schoelly Imaging, Inc. on under FDA product code FWF (Camera, Television, Endoscopic, Without Audio). FDA records list 5 510(k) clearances for Schoelly Imaging, Inc., from to . As of , FDA records show no recalls naming K053412.

Clearance record

Decision date
Received
(78 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
Schoelly Imaging, Inc. 5 Whitcomb Ave., Ayer MA
510(k) summary
Summary PDF
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