510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K053250Substantially Equivalent

Ans 90 Cm and 110 Cm (3100 and 3200 Series) Lead Kit

Abbott Medical, Plano TX / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K053250 is the FDA 510(k) clearance record for ANS 90 CM AND 110 CM (3100 AND 3200 SERIES) LEAD KIT, a class II device, cleared for Advanced Neuromodulation Systems on under FDA product code GZB (Stimulator, Spinal-Cord, Implanted (Pain Relief)). FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show no recalls naming K053250.

Clearance record

Decision date
Received
(24 days to decision)
Product code
GZB Stimulator, Spinal-Cord, Implanted (Pain Relief)
Regulation
21 CFR 882.5880
Device class
Class II
Review panel
Neurology
Applicant
Advanced Neuromodulation Systems 6901 Preston Rd., Plano TX
510(k) summary
Statement
Third party review
No

Clearances, product code GZB

Trailing 12 months

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

FDA records show no clearances under product code GZB in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GZB, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260