510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K022836Substantially Equivalent

Stephens Disposable Speculum

Stephens Instruments, Inc, Lexington KY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K022836 is the FDA 510(k) clearance record for STEPHENS DISPOSABLE SPECULUM, a class I device, cleared for Stephens Instruments on under FDA product code HNC (Specula, Ophthalmic). FDA records list 5 510(k) clearances for Stephens Instruments. As of , FDA records show no recalls naming K022836.

Clearance record

Decision date
Received
(66 days to decision)
Product code
HNC Specula, Ophthalmic
Regulation
21 CFR 886.4350
Device class
Class I
Review panel
Ophthalmic
Applicant
Stephens Instruments 2500 Sandersville Rd., Lexington KY
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HNC

Trailing 12 months

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

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