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FDA 510(k)

SURGICLA INSTRUMENT KIT

K-Number: K946019 · 1995-03-20

ApplicantMedical Action Industries, Inc.
Decision Date1995-03-20
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SURGICLA INSTRUMENT KIT is the device name listed in this FDA 510(k) record. The listed applicant is Medical Action Industries, Inc.. It received FDA 510(k) clearance on 1995-03-20 under 510(k) number K946019. The device is classified under product code FRG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGICLA INSTRUMENT KIT?

SURGICLA INSTRUMENT KIT is a medical device that received FDA 510(k) clearance on 1995-03-20. The listed applicant is Medical Action Industries, Inc.. The 510(k) number is K946019.

When did SURGICLA INSTRUMENT KIT receive FDA 510(k) clearance?

SURGICLA INSTRUMENT KIT received FDA 510(k) clearance on 1995-03-20, under 510(k) number K946019.

Who is the listed applicant for SURGICLA INSTRUMENT KIT?

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

What is the FDA product code for SURGICLA INSTRUMENT KIT?

The FDA product code for SURGICLA INSTRUMENT KIT is FRG.

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Other records listing Medical Action Industries, 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.

K042526DRAPE, SURGICAL, X-RAY ELEMENT, MODELS NON STERILE 6120-00, STERILE 704-B, NON STERILE 6124-00X, STERILE 704-BXK042527SPATULA, CERVICAL, CYTOLOGICAL, MODEL 22-9107K022948VAGINAL SPECULUM, MODEL 5555S, 5555M, OR 5555LK923846BURN DRESSINGK884826GAUZE SPONGEK810685SUTURE REMOVAL KIT

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Related Devices (Code: FRG)

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.

K261897HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* H300W Sterilization Wrap with ASSURE-DRY* TechnologyO&M Halyard, Inc.K252823Dukal Crepe Paper Sterilization WrapDukal, LLCK253454HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization WrapO&M Halyard, Inc.K251347Sterilization Pouch/RollSterivic Medical Co., Ltd.K251177Self-Seal Sterilization Pouch and RollGuangdong Maidi Medical Co., Ltd.K250306Chex-All Sterilization Pouches and TubesPropper Manufacturing Co., 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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