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FDA 510(k)

HARWILL MEDICAL CERVITULA CERVICAL SPATULA

K-Number: K983202 · 1999-03-15

ApplicantHarwill Medical (Pty) , Ltd.
Decision Date1999-03-15
Product CodeHHT
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

HARWILL MEDICAL CERVITULA CERVICAL SPATULA is the device name listed in this FDA 510(k) record. The listed applicant is Harwill Medical (Pty) , Ltd.. It received FDA 510(k) clearance on 1999-03-15 under 510(k) number K983202. 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 HARWILL MEDICAL CERVITULA CERVICAL SPATULA?

HARWILL MEDICAL CERVITULA CERVICAL SPATULA is a medical device that received FDA 510(k) clearance on 1999-03-15. The listed applicant is Harwill Medical (Pty) , Ltd.. The 510(k) number is K983202.

When did HARWILL MEDICAL CERVITULA CERVICAL SPATULA receive FDA 510(k) clearance?

HARWILL MEDICAL CERVITULA CERVICAL SPATULA received FDA 510(k) clearance on 1999-03-15, under 510(k) number K983202.

Who is the listed applicant for HARWILL MEDICAL CERVITULA CERVICAL SPATULA?

The FDA 510(k) record lists Harwill Medical (Pty) , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HARWILL MEDICAL CERVITULA CERVICAL SPATULA?

The FDA product code for HARWILL MEDICAL CERVITULA CERVICAL SPATULA is HHT.

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Other records listing Harwill Medical (Pty) , Ltd. 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.

K992618RESPALERTK983204HARWILL MEDICAL U-KLIP UMBILICAL CLAMPK980550WHISTLE WATCH

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

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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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