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FDA 510(k)

INTEGRATED DRIVE/PUMP SYSTEM FOR OTOLARYNGOLOGY

K-Number: K981637 · 1998-07-20

ApplicantLinvatec Corp.
Decision Date1998-07-20
Product CodeERL
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

INTEGRATED DRIVE/PUMP SYSTEM FOR OTOLARYNGOLOGY is the device name listed in this FDA 510(k) record. The listed applicant is Linvatec Corp.. It received FDA 510(k) clearance on 1998-07-20 under 510(k) number K981637. 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 INTEGRATED DRIVE/PUMP SYSTEM FOR OTOLARYNGOLOGY?

INTEGRATED DRIVE/PUMP SYSTEM FOR OTOLARYNGOLOGY is a medical device that received FDA 510(k) clearance on 1998-07-20. The listed applicant is Linvatec Corp.. The 510(k) number is K981637.

When did INTEGRATED DRIVE/PUMP SYSTEM FOR OTOLARYNGOLOGY receive FDA 510(k) clearance?

INTEGRATED DRIVE/PUMP SYSTEM FOR OTOLARYNGOLOGY received FDA 510(k) clearance on 1998-07-20, under 510(k) number K981637.

Who is the listed applicant for INTEGRATED DRIVE/PUMP SYSTEM FOR OTOLARYNGOLOGY?

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

What is the FDA product code for INTEGRATED DRIVE/PUMP SYSTEM FOR OTOLARYNGOLOGY?

The FDA product code for INTEGRATED DRIVE/PUMP SYSTEM FOR OTOLARYNGOLOGY is ERL.

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Other records listing Linvatec Corp. 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.

K092998CONMED LINVATEC INTERCEPT IMPLANTK091549CONMED LINVATEC SOFT TISSUE TO BONE SYSTEMK090835CONMED LINVATEC BIO MINI-REVO SUTURE ANCHOR, MODEL C6170CRK090186CONMED LINVATEC PALADIN, PRELOADED WITH TWO #2 HI-FI SUTURESK083281EL LIGHTWAVE SUCTION ABLATOR, MODEL EL-2000-S, LIGHTWAVE SUCTION ABLATOR, MODEL IA-2000-S, LIGHTWAVE ABLATOR, MODEL IA-K060198MICROPOWER HAND PIECE : MEDIUM SPEED DRILL, SAGGITAL SAW, RECIPROCATING SAW, AND OSCILLATING SAW

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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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