510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K851799Substantially Equivalent

61-100 to 61-124 Various Vaginal Specvia(cusco,gra

Artiberia, San Antonio TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K851799 is the FDA 510(k) clearance record for 61-100 TO 61-124 VARIOUS VAGINAL SPECVIA(CUSCO,GRA, a class I device, cleared for Artiberia on under FDA product code HDF (Speculum, Vaginal, Metal). FDA records list 79 510(k) clearances for Artiberia, from to . As of , FDA records show no recalls naming K851799.

Clearance record

Decision date
Received
(27 days to decision)
Product code
HDF Speculum, Vaginal, Metal
Regulation
21 CFR 884.4520
Device class
Class I
Review panel
Obstetrics/Gynecology
Applicant
Artiberia 4518 Los Ranchitos, San Antonio TX
Third party review
No

Clearances, product code HDF

Trailing 12 months

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

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