510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K823901Substantially Equivalent

Trephine Blades-Various Models

Edward Weck, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K823901 is the FDA 510(k) clearance record for TREPHINE BLADES-VARIOUS MODELS, a class I device, cleared for Edward Weck, Inc. on under FDA product code HRG (Engine, Trephine, Accessories, Ac-Powered). FDA records list 140 510(k) clearances for Edward Weck, Inc., from to . As of , FDA records show no recalls naming K823901.

Clearance record

Decision date
Received
(18 days to decision)
Product code
HRG Engine, Trephine, Accessories, Ac-Powered
Regulation
21 CFR 886.4070
Device class
Class I
Review panel
Ophthalmic
Applicant
Edward Weck, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code HRG

Trailing 12 months

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

FDA records show no clearances under product code HRG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HRG, 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