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FDA 510(k)

SPATULA, CERVICAL, CYTOLOGICAL, MODEL 22-9107

K-Number: K042527 · 2004-11-08

ApplicantMedical Action Industries, Inc.
Decision Date2004-11-08
Product CodeHHT
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SPATULA, CERVICAL, CYTOLOGICAL, MODEL 22-9107 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 2004-11-08 under 510(k) number K042527. The device is classified under product code HHT. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPATULA, CERVICAL, CYTOLOGICAL, MODEL 22-9107?

SPATULA, CERVICAL, CYTOLOGICAL, MODEL 22-9107 is a medical device that received FDA 510(k) clearance on 2004-11-08. The listed applicant is Medical Action Industries, Inc.. The 510(k) number is K042527.

When did SPATULA, CERVICAL, CYTOLOGICAL, MODEL 22-9107 receive FDA 510(k) clearance?

SPATULA, CERVICAL, CYTOLOGICAL, MODEL 22-9107 received FDA 510(k) clearance on 2004-11-08, under 510(k) number K042527.

Who is the listed applicant for SPATULA, CERVICAL, CYTOLOGICAL, MODEL 22-9107?

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 SPATULA, CERVICAL, CYTOLOGICAL, MODEL 22-9107?

The FDA product code for SPATULA, CERVICAL, CYTOLOGICAL, MODEL 22-9107 is HHT.

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Other records listing Medical Action Industries, Inc. as applicant

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K042526DRAPE, SURGICAL, X-RAY ELEMENT, MODELS NON STERILE 6120-00, STERILE 704-B, NON STERILE 6124-00X, STERILE 704-BXK022948VAGINAL SPECULUM, MODEL 5555S, 5555M, OR 5555LK946019SURGICLA INSTRUMENT KITK923846BURN DRESSINGK884826GAUZE SPONGEK810685SUTURE REMOVAL KIT

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Related Devices (Code: HHT)

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.

K182049exCellerator Cervical Collection DeviceExcell Company, LLCK153128Kolplast Cervical Sample Collection KitKolplast CI SAK111681HISTOBRUSHPuritan Medical Products Company, LLCK083012PAPCONEOtto Bock Pur Life Science GmbHK081522BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGYBio Nuclear Diagnostics, Inc.K072381SOFTPAP CERVICAL CELL COLLECTORCytocore, 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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