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FDA 510(k)

CYTOLOGICAL CERVICAL SPATULA THE MULTI-SPATULA

K-Number: K851934 · 1985-07-05

ApplicantTridak Division of Indicon, Inc.
Decision Date1985-07-05
Product CodeHHT
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

CYTOLOGICAL CERVICAL SPATULA THE MULTI-SPATULA is the device name listed in this FDA 510(k) record. The listed applicant is Tridak Division of Indicon, Inc.. It received FDA 510(k) clearance on 1985-07-05 under 510(k) number K851934. 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 CYTOLOGICAL CERVICAL SPATULA THE MULTI-SPATULA?

CYTOLOGICAL CERVICAL SPATULA THE MULTI-SPATULA is a medical device that received FDA 510(k) clearance on 1985-07-05. The listed applicant is Tridak Division of Indicon, Inc.. The 510(k) number is K851934.

When did CYTOLOGICAL CERVICAL SPATULA THE MULTI-SPATULA receive FDA 510(k) clearance?

CYTOLOGICAL CERVICAL SPATULA THE MULTI-SPATULA received FDA 510(k) clearance on 1985-07-05, under 510(k) number K851934.

Who is the listed applicant for CYTOLOGICAL CERVICAL SPATULA THE MULTI-SPATULA?

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

What is the FDA product code for CYTOLOGICAL CERVICAL SPATULA THE MULTI-SPATULA?

The FDA product code for CYTOLOGICAL CERVICAL SPATULA THE MULTI-SPATULA is HHT.

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Other records listing Tridak Division of Indicon, Inc. as applicant

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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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