510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K253580Substantially Equivalent

Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S)

Tedan Surgical Innovations, Inc., Sugar Land TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K253580 is the FDA 510(k) clearance record for Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S), a class II device, cleared for Tedan Surgical Innovations on under FDA product code PDQ (Neurosurgical Nerve Locator). FDA's definition for product code PDQ reads: "To locate or monitor function of spinal nerve roots or peripheral nerves during neurosurgery". FDA records list 4 510(k) clearances for Tedan Surgical Innovations, from to . As of , FDA records show no recalls naming K253580.

Clearance record

Decision date
Received
(160 days to decision)
Product code
PDQ Neurosurgical Nerve Locator
Regulation
21 CFR 874.1820
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Tedan Surgical Innovations 12320 Cardinal Meadow Dr., Sugar Land TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PDQ

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