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FDA 510(k)

PENTAX Medical Auto Leakage Tester SHA-P6

K-Number: K212201 · 2021-10-01

ApplicantPentax of America, Inc.
Decision Date2021-10-01
Product CodePCV
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PENTAX Medical Auto Leakage Tester SHA-P6 is the device name listed in this FDA 510(k) record. The listed applicant is Pentax of America, Inc.. It received FDA 510(k) clearance on 2021-10-01 under 510(k) number K212201. The device is classified under product code PCV. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PENTAX Medical Auto Leakage Tester SHA-P6?

PENTAX Medical Auto Leakage Tester SHA-P6 is a medical device that received FDA 510(k) clearance on 2021-10-01. The listed applicant is Pentax of America, Inc.. The 510(k) number is K212201.

When did PENTAX Medical Auto Leakage Tester SHA-P6 receive FDA 510(k) clearance?

PENTAX Medical Auto Leakage Tester SHA-P6 received FDA 510(k) clearance on 2021-10-01, under 510(k) number K212201.

Who is the listed applicant for PENTAX Medical Auto Leakage Tester SHA-P6?

The FDA 510(k) record lists Pentax of America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PENTAX Medical Auto Leakage Tester SHA-P6?

The FDA product code for PENTAX Medical Auto Leakage Tester SHA-P6 is PCV.

Other records listing Pentax of America, Inc. 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.

K251256PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family)K251127PENTAX Medical Video Processor (EPK-i8020c)K242110PENTAX Medical Video Colonoscope (EC38-i20cWL)K241213PENTAX Medical Video Upper GI Scope (EG27-i20c); PENTAX Medical Video Colonoscope (EC34-i20cL)K233942PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor (EPK-i8020c); PENTAX Medical Single Use, Sterile Distal End Cap with Elevator (OE-A63); Gas/Water Feeding Valves (OF-B194 )K240457C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)

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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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