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FDA 510(k)

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

K-Number: K253580 · 2026-04-26

ApplicantTedan Surgical Innovations
Decision Date2026-04-26
Product CodePDQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S) is the device name listed in this FDA 510(k) record. The listed applicant is Tedan Surgical Innovations. It received FDA 510(k) clearance on 2026-04-26 under 510(k) number K253580. The device is classified under product code PDQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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

Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S) is a medical device that received FDA 510(k) clearance on 2026-04-26. The listed applicant is Tedan Surgical Innovations. The 510(k) number is K253580.

When did Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S) receive FDA 510(k) clearance?

Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S) received FDA 510(k) clearance on 2026-04-26, under 510(k) number K253580.

Who is the listed applicant for Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S)?

The FDA 510(k) record lists Tedan Surgical Innovations as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S)?

The FDA product code for Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S) is PDQ.

Other records listing Tedan Surgical Innovations as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K231691Phantom XL Insulated DilatorsK161318Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems

Related Devices (Code: PDQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260992iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball Tip Probe (NTX-9007)NeuralytixK243636Neuralytix iD3 System (NTX-9001)Neuralytix, LLCK223438TELIGEN System Peripheral Motor Nerve Stimulation IndicationsMedos International SARLK221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.K220160PediGuard ThreadedSpineguard S.A.K203684Neurosign V4 Intraoperative Nerve MonitorMagstim Company, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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