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FDA 510(k)

ENT IRRIGATING PUMP (70327700)

K-Number: K973286 · 1997-09-29

ApplicantGyrus Ent LLC
Decision Date1997-09-29
Product CodeERL
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ENT IRRIGATING PUMP (70327700) is the device name listed in this FDA 510(k) record. The listed applicant is Gyrus Ent LLC. It received FDA 510(k) clearance on 1997-09-29 under 510(k) number K973286. The device is classified under product code ERL. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENT IRRIGATING PUMP (70327700)?

ENT IRRIGATING PUMP (70327700) is a medical device that received FDA 510(k) clearance on 1997-09-29. The listed applicant is Gyrus Ent LLC. The 510(k) number is K973286.

When did ENT IRRIGATING PUMP (70327700) receive FDA 510(k) clearance?

ENT IRRIGATING PUMP (70327700) received FDA 510(k) clearance on 1997-09-29, under 510(k) number K973286.

Who is the listed applicant for ENT IRRIGATING PUMP (70327700)?

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

What is the FDA product code for ENT IRRIGATING PUMP (70327700)?

The FDA product code for ENT IRRIGATING PUMP (70327700) is ERL.

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Other records listing Gyrus Ent LLC 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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Related Devices (Code: ERL)

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.

K243280Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories)W&H Dentalwerk Buermoos GmbHK233958hekaDrillZethon, Ltd.K221184ORiGO SystemBien-Air Surgery SAK213221AMADEO, M-UK1015 (incl. attachments and accessories)W&H Dentalwerk Buermoss GmbHK212650Celeris, Disposable Sinus DebriderGyrus Acmi, Inc.K211490Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000Stryker Corporation

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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