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FDA 510(k)

DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADES

K-Number: K954989 · 1995-11-27

ApplicantSmith & Nephew Dyonics, Inc.
Decision Date1995-11-27
Product CodeERL
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADES is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew Dyonics, Inc.. It received FDA 510(k) clearance on 1995-11-27 under 510(k) number K954989. 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 DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADES?

DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADES is a medical device that received FDA 510(k) clearance on 1995-11-27. The listed applicant is Smith & Nephew Dyonics, Inc.. The 510(k) number is K954989.

When did DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADES receive FDA 510(k) clearance?

DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADES received FDA 510(k) clearance on 1995-11-27, under 510(k) number K954989.

Who is the listed applicant for DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADES?

The FDA 510(k) record lists Smith & Nephew Dyonics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADES?

The FDA product code for DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADES is ERL.

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Other records listing Smith & Nephew Dyonics, 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.

K955914LIMITED REUSE ARTHROSCOPIC BLADESK954627ECTRA II LIGAMENT RELEASE SYSTEMK953695DYONICS DISPOSABLE ARTHROSCOPIC BLADESK953387ECTRA LIGAMENT RELEASE SYSTEMK945182DYONICS FIXATION SCREWSK936071SMITH & NEPHEW DYONICS INC. ELECTRONIC ENDOSCOPE

View all 22 devices →

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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