510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K982754Substantially Equivalent

Ec-1000-7 Digital Endoscopy Video Camera, Models Ec 1000-7P (Pal) & Ec 1000-7N (Ntsc)

A.Stein - Regulatory Affairs Consulting, Ginot Shomron 44853, IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K982754 is the FDA 510(k) clearance record for EC-1000-7 DIGITAL ENDOSCOPY VIDEO CAMERA, MODELS EC 1000-7P (PAL) & EC 1000-7N (NTSC), a class I device, cleared for A.Stein - Regulatory Affairs Consulting on under FDA product code FWF (Camera, Television, Endoscopic, Without Audio). FDA records list 5 510(k) clearances for A.Stein - Regulatory Affairs Consulting, from to . As of , FDA records show no recalls naming K982754.

Clearance record

Decision date
Received
(155 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
A.Stein - Regulatory Affairs Consulting P.o.b. 454, Ginot Shomron 44853, IL
510(k) summary
Statement
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