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FDA 510(k)

FLEXTIP GRASPER

K-Number: K972450 · 1997-11-21

ApplicantEndius, Inc.
Decision Date1997-11-21
Product CodeEOB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

FLEXTIP GRASPER is the device name listed in this FDA 510(k) record. The listed applicant is Endius, Inc.. It received FDA 510(k) clearance on 1997-11-21 under 510(k) number K972450. The device is classified under product code EOB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLEXTIP GRASPER?

FLEXTIP GRASPER is a medical device that received FDA 510(k) clearance on 1997-11-21. The listed applicant is Endius, Inc.. The 510(k) number is K972450.

When did FLEXTIP GRASPER receive FDA 510(k) clearance?

FLEXTIP GRASPER received FDA 510(k) clearance on 1997-11-21, under 510(k) number K972450.

Who is the listed applicant for FLEXTIP GRASPER?

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

What is the FDA product code for FLEXTIP GRASPER?

The FDA product code for FLEXTIP GRASPER is EOB.

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Other records listing Endius, 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.

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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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