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FDA 510(k)

ULTRAFLOW SUCTION-IRRIGATION CANNULA

K-Number: K921335 · 1994-02-03

ApplicantEndoscopic Surgical Products, Inc.
Decision Date1994-02-03
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ULTRAFLOW SUCTION-IRRIGATION CANNULA is the device name listed in this FDA 510(k) record. The listed applicant is Endoscopic Surgical Products, Inc.. It received FDA 510(k) clearance on 1994-02-03 under 510(k) number K921335. The device is classified under product code HET. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRAFLOW SUCTION-IRRIGATION CANNULA?

ULTRAFLOW SUCTION-IRRIGATION CANNULA is a medical device that received FDA 510(k) clearance on 1994-02-03. The listed applicant is Endoscopic Surgical Products, Inc.. The 510(k) number is K921335.

When did ULTRAFLOW SUCTION-IRRIGATION CANNULA receive FDA 510(k) clearance?

ULTRAFLOW SUCTION-IRRIGATION CANNULA received FDA 510(k) clearance on 1994-02-03, under 510(k) number K921335.

Who is the listed applicant for ULTRAFLOW SUCTION-IRRIGATION CANNULA?

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

What is the FDA product code for ULTRAFLOW SUCTION-IRRIGATION CANNULA?

The FDA product code for ULTRAFLOW SUCTION-IRRIGATION CANNULA is HET.

Related Clinical Trials

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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Other records listing Endoscopic Surgical Products, 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.

K921336TROCAR GRASPER/ANVIL APPROXIMATOR

Related Devices (Code: HET)

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.

K250939SIRIUS Endoscope System (PR-SI-1230)Precision Robotics (Hong Kong) LimitedK243821i-CutA.M.I. Agency For Medical Innovations GmbHK221642SIRIUS Endoscope SystemPrecision Robotics (Hong Kong) LimitedK210116Video Endoscopy System, 3D Video Endoscopy SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.K201832Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5Olympus Medical Systems Corp.K210104SurroundScope System270surgical , Ltd.

Official Source

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