510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K801608Substantially Equivalent

Mcculley Continuous Suture Tightner

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

K801608 is the FDA 510(k) clearance record for MCCULLEY CONTINUOUS SUTURE TIGHTNER, a class I device, cleared for Edward Weck, Inc. on under FDA product code HND (Spatula, Ophthalmic). FDA records list 140 510(k) clearances for Edward Weck, Inc., from to . As of , FDA records show no recalls naming K801608.

Clearance record

Decision date
Received
(28 days to decision)
Product code
HND Spatula, Ophthalmic
Regulation
21 CFR 886.4350
Device class
Class I
Review panel
Ophthalmic
Applicant
Edward Weck, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code HND

Trailing 12 months

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

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