510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K033730Substantially Equivalent

Pmt Sphenoidal Electrode and Accessory, Model 2101-31 and 2102-31 Series

PMT Corp., Chanhassen MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K033730 is the FDA 510(k) clearance record for PMT SPHENOIDAL ELECTRODE AND ACCESSORY, MODEL 2101-31 AND 2102-31 SERIES, a class II device, cleared for Pmt Corp. on under FDA product code GZL (Electrode, Depth). FDA records list 22 510(k) clearances for Pmt Corp., from to . As of , FDA records show no recalls naming K033730.

Clearance record

Decision date
Received
(249 days to decision)
Product code
GZL Electrode, Depth
Regulation
21 CFR 882.1330
Device class
Class II
Review panel
Neurology
Applicant
Pmt Corp. 1500 Park Rd., Chanhassen MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GZL

Trailing 12 months
2 clearances under product code GZL in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GZL, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260