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FDA 510(k)

STONE GRASPING BASKET, MODEL PD-T1 2115

K-Number: K082735 · 2009-03-13

ApplicantSialo Technology, Ltd.
Decision Date2009-03-13
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

STONE GRASPING BASKET, MODEL PD-T1 2115 is the device name listed in this FDA 510(k) record. The listed applicant is Sialo Technology, Ltd.. It received FDA 510(k) clearance on 2009-03-13 under 510(k) number K082735. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STONE GRASPING BASKET, MODEL PD-T1 2115?

STONE GRASPING BASKET, MODEL PD-T1 2115 is a medical device that received FDA 510(k) clearance on 2009-03-13. The listed applicant is Sialo Technology, Ltd.. The 510(k) number is K082735.

When did STONE GRASPING BASKET, MODEL PD-T1 2115 receive FDA 510(k) clearance?

STONE GRASPING BASKET, MODEL PD-T1 2115 received FDA 510(k) clearance on 2009-03-13, under 510(k) number K082735.

Who is the listed applicant for STONE GRASPING BASKET, MODEL PD-T1 2115?

The FDA 510(k) record lists Sialo Technology, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STONE GRASPING BASKET, MODEL PD-T1 2115?

The FDA product code for STONE GRASPING BASKET, MODEL PD-T1 2115 is GCJ.

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Other records listing Sialo Technology, Ltd. 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.

K093785MODULAR ENDOSCOPEK072334SIALO DRAINK072749SIALO BALLOON DILATATION CATHETER

Related Devices (Code: GCJ)

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.

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Official Source

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

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