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FDA 510(k)

ENDOMEDIX Y-ADAPTER

K-Number: K934170 · 1994-01-11

ApplicantEndomedix
Decision Date1994-01-11
Product CodeOCX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENDOMEDIX Y-ADAPTER is the device name listed in this FDA 510(k) record. The listed applicant is Endomedix. It received FDA 510(k) clearance on 1994-01-11 under 510(k) number K934170. The device is classified under product code OCX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOMEDIX Y-ADAPTER?

ENDOMEDIX Y-ADAPTER is a medical device that received FDA 510(k) clearance on 1994-01-11. The listed applicant is Endomedix. The 510(k) number is K934170.

When did ENDOMEDIX Y-ADAPTER receive FDA 510(k) clearance?

ENDOMEDIX Y-ADAPTER received FDA 510(k) clearance on 1994-01-11, under 510(k) number K934170.

Who is the listed applicant for ENDOMEDIX Y-ADAPTER?

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

What is the FDA product code for ENDOMEDIX Y-ADAPTER?

The FDA product code for ENDOMEDIX Y-ADAPTER is OCX.

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Other records listing Endomedix 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.

K934623ENDOSCOPIC VIDEO SYSTEM AND ENDOSCOPIC VIDEO CAMERAK930499GRASPING FORCEPS FLEXIBLE STONE DISLODGERK930349STONE RETRIEVAL BASKETK926004ENDOSCOPE AND ACCOSSORIESK922837S1500 XENON LIGHT SOURCEK922082LAPAROSCOPIC INTRODUCER

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Related Devices (Code: OCX)

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

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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