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FDA 510(k)

XOMED-TREACE POSITROL FOOTPEDAL SUCTION CONTROL

K-Number: K912753 · 1991-09-23

ApplicantXomed-Treace, Inc.
Decision Date1991-09-23
Product CodeGCX
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

XOMED-TREACE POSITROL FOOTPEDAL SUCTION CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Xomed-Treace, Inc.. It received FDA 510(k) clearance on 1991-09-23 under 510(k) number K912753. The device is classified under product code GCX. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XOMED-TREACE POSITROL FOOTPEDAL SUCTION CONTROL?

XOMED-TREACE POSITROL FOOTPEDAL SUCTION CONTROL is a medical device that received FDA 510(k) clearance on 1991-09-23. The listed applicant is Xomed-Treace, Inc.. The 510(k) number is K912753.

When did XOMED-TREACE POSITROL FOOTPEDAL SUCTION CONTROL receive FDA 510(k) clearance?

XOMED-TREACE POSITROL FOOTPEDAL SUCTION CONTROL received FDA 510(k) clearance on 1991-09-23, under 510(k) number K912753.

Who is the listed applicant for XOMED-TREACE POSITROL FOOTPEDAL SUCTION CONTROL?

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

What is the FDA product code for XOMED-TREACE POSITROL FOOTPEDAL SUCTION CONTROL?

The FDA product code for XOMED-TREACE POSITROL FOOTPEDAL SUCTION CONTROL is GCX.

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Other records listing Xomed-Treace, 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.

K940028ENDOSCOPE SHEATHK941407TYMPANOSTOMY (VENTILATION) TUBEK945659BLACKSTAR(TM) STAR SYSTEMK932771BATTERY POWERED, DISPOSABLE ENDOSCOPE LIGHT SOURCEK933672XOMED-TREACE SCOPESHEATHK934426NERVE INTEGRITY MONITOR-2 (NIM-2 XL)

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Related Devices (Code: GCX)

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.

K042454STRYKER CASSETTE PUMPStryker EndoscopyK992126CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEMCircon Corp.K972074SUCTION INSTRUMENTATIONWalter Lorenz Surgical, Inc.K971022CHASE SUCKERChase Medical, Inc.K964127MEDI-VAC FLEXI-CLEAR SUCTION HANDLEAllegiance Healthcare Corp.K964519CURITY THORACENTESIS TRAYKendall Healthcare Products Co. Div.Of Tyco Health

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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