510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K881857Substantially Equivalent

Amnicath(tm) Model Dt-Iupc Trans. Tipped Intrau.

Spectramed, LLC, Oxnard CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K881857 is the FDA 510(k) clearance record for AMNICATH(TM) MODEL DT-IUPC TRANS. TIPPED INTRAU., a class II device, cleared for Spectramed, Inc. on under FDA product code KXO (Monitor, Pressure, Intrauterine). FDA records list 20 510(k) clearances for Spectramed, Inc., from to . As of , FDA records show no recalls naming K881857.

Clearance record

Decision date
Received
(274 days to decision)
Product code
KXO Monitor, Pressure, Intrauterine
Regulation
21 CFR 884.2700
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Spectramed, Inc. 1900 Williams Dr., Oxnard CA
Third party review
No

Clearances, product code KXO

Trailing 12 months

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

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