510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K911657Substantially Equivalent

Fetal Scalp Spiral Electrode

Advanced Medical Systems, Inc., Hamden CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K911657 is the FDA 510(k) clearance record for FETAL SCALP SPIRAL ELECTRODE, a class II device, cleared for Advanced Medical Systems, Inc. on under FDA product code HGP (Electrode, Circular (Spiral), Scalp And Applicator). FDA records list 10 510(k) clearances for Advanced Medical Systems, Inc., from to . As of , FDA records show no recalls naming K911657.

Clearance record

Decision date
Received
(90 days to decision)
Product code
HGP Electrode, Circular (Spiral), Scalp And Applicator
Regulation
21 CFR 884.2675
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Advanced Medical Systems, Inc. 925 Sherman Ave., Hamden CT
Third party review
No

Clearances, product code HGP

Trailing 12 months

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

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