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FDA 510(k)

SIMPEX INC. SURGICAL DRESSING

K-Number: K913794 · 1991-11-20

ApplicantSimpex, Inc.
Decision Date1991-11-20
Product CodeGDY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SIMPEX INC. SURGICAL DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Simpex, Inc.. It received FDA 510(k) clearance on 1991-11-20 under 510(k) number K913794. The device is classified under product code GDY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIMPEX INC. SURGICAL DRESSING?

SIMPEX INC. SURGICAL DRESSING is a medical device that received FDA 510(k) clearance on 1991-11-20. The listed applicant is Simpex, Inc.. The 510(k) number is K913794.

When did SIMPEX INC. SURGICAL DRESSING receive FDA 510(k) clearance?

SIMPEX INC. SURGICAL DRESSING received FDA 510(k) clearance on 1991-11-20, under 510(k) number K913794.

Who is the listed applicant for SIMPEX INC. SURGICAL DRESSING?

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

What is the FDA product code for SIMPEX INC. SURGICAL DRESSING?

The FDA product code for SIMPEX INC. SURGICAL DRESSING is GDY.

Related Clinical Trials

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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Other records listing Simpex, 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.

K920174EASY TOUCH LATEX EAM GLOVESK913793SIMPEX INC. ORAL AND RECTAL THERMOMETERSK911452FIXATION PINK911505FIXATION WIRE

Related Devices (Code: GDY)

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.

K972634ULTRACELL SUCTION SPONGEUltracell Medical Technologies, Inc.K960236CPR LAP SPONGESCustom Pack ReliabilityK955599STRYKER FEMORAL CANAL SPONGE & ACETABULUM SPONGEStryker Corp.K955322PROTEC X-RAY DETECTABLE GAUZE SPONGEDerivados DE Gasa, S.A. DE C.V.K953830KENSORBKentron Health Care, Inc.K953060ROSEBUD DISSECTORMedical Perspectives Corp.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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