510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K851797Substantially Equivalent

53-100 to 53-120 Various Rectal Specula(sims, Math

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

K851797 is the FDA 510(k) clearance record for 53-100 TO 53-120 VARIOUS RECTAL SPECULA(SIMS, MATH, a class I device, cleared for Artiberia on under FDA product code FFQ (Speculum, Rectal). FDA records list 79 510(k) clearances for Artiberia, from to . As of , FDA records show no recalls naming K851797.

Clearance record

Decision date
Received
(28 days to decision)
Product code
FFQ Speculum, Rectal
Regulation
21 CFR 876.4730
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
Artiberia 4518 Los Ranchitos, San Antonio TX
Third party review
No

Clearances, product code FFQ

Trailing 12 months

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

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