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FDA 510(k)

POOLE TIP SUCTION PROBE

K-Number: K931950 · 1993-08-11

ApplicantMayaguez Medical Center
Decision Date1993-08-11
Product CodeGCY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

POOLE TIP SUCTION PROBE is the device name listed in this FDA 510(k) record. The listed applicant is Mayaguez Medical Center. It received FDA 510(k) clearance on 1993-08-11 under 510(k) number K931950. The device is classified under product code GCY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POOLE TIP SUCTION PROBE?

POOLE TIP SUCTION PROBE is a medical device that received FDA 510(k) clearance on 1993-08-11. The listed applicant is Mayaguez Medical Center. The 510(k) number is K931950.

When did POOLE TIP SUCTION PROBE receive FDA 510(k) clearance?

POOLE TIP SUCTION PROBE received FDA 510(k) clearance on 1993-08-11, under 510(k) number K931950.

Who is the listed applicant for POOLE TIP SUCTION PROBE?

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

What is the FDA product code for POOLE TIP SUCTION PROBE?

The FDA product code for POOLE TIP SUCTION PROBE is GCY.

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Other records listing Mayaguez Medical Center 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.

K93280510.0MM SUCTION/IRRIGATION PROBE & TUBING KITK932804IRRIGATING TAPERED PROBEK932806POOLE TIP SUCTION PROBE & TUBING KITK931854ENDOSCOPIC BLUNT DISSECTING INSTRUMENTK931912IRRIGATING BLUNT DISSECTORK9318565.0 MM IRRIGATION/ASPIRATION PROBE

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Related Devices (Code: GCY)

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.

K972703REDYROB-CLOSED WOUND DRAINAGE SYSTEMB.Braun Medical, Inc.K971036ODONTIT AUTOGENOUS BONE COLLECTION DEVICEInterpore Intl.K963839CORDIS SUCTION RESERVOIR - MODEL NUMBER: 910-500Cordis Corp.K960099PENROSE DRAIN MODELS 6001 - 6007Sil-Med Corp.K950754MACRO SUCTION TUBE MODEL NO 10061Dlp, Inc.K936223PRESSURE IRRIGATING SYSTEMLevel 1 Technologies, Inc.

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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